Dupuytren's Contracture Treatments
Number: 0800
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses treatments for Dupuytren's contracture for commercial medical plans.
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Medical Necessity
Aetna considers the following interventions as medically necessary for the management of Dupuytren's contracture:
- For collagenase clostridium histolyticum (Xiaflex) in the treatment of Dupuytren's contracture, see CPB 1061 - Collagenase Clostridium Histolyticum (Xiaflex);
- Intralesional glucocorticoid injection in early-stage Dupuytren's for treatment of local tenderness (tenosynovitis) or for rapidly growing palmar nodules;
- Ortho-voltage radiation for treatment of early-stage Dupuytren's contracture (stage N, N/I). (Note: stage N: nodules/cords, no extension deficit = flexion deformity; stage N/I: less than or equal to 10 degrees deficit);
- Percutaneous needle aponeurotomy (also known as percutaneous needle fasciotomy) for the treatment of adults with Dupuytren's contracture if the member has a finger flexion contracture with a palpable cord in a metacarpophalangeal joint or a proximal interphalangeal joint, the contracture is at least 20 degrees and the member had a positive table top test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a table.
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Experimental, Investigational, or Unproven
Aetna considers the following interventions experimental, investigational, or unproven (not an all-inclusive list) for management of Dupuytren's contracture (DC):
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- Anti-tumor necrosis factor therapy
- Autologous fat grafting
- Collagenase nanocapsules
- Combined percutaneous needle aponeurotomy and lipografting for the treatment of adults with DC
- Continuous slow skeletal traction
- Cryopreserved placental membrane
- Dermofasciectomy for the primary treatment of Dupuytren disease
- Digit Widget for the treatment of proximal inter-phalangeal (PIP) flexion contractures
- Dynamic manugraphy for the evaluation of the outcome of aponeurectomy in persons with DC
- Extracorporeal shock wave therapy for prevention of the progression as well as for the treatment of DC
- Interferon
- Middle-phalanx excision and ligament reconstruction
- Night-time splinting / orthosis for all individuals after fasciectomy or dermofasciectomy for DC
- Peri-operative 192-Ir high dose rate brachytherapy for improving outcomes of aponeurotomy for DC
- Sono-Bath (percutaneous sonography-guided technique) for the treatment of DC
- Ultrasound therapy.
Background
Dupuytren's disease, a progressive fibro-proliferative disorder, is characterized by nodule formation and contracture of the palmar fascia, and may result in flexion deformity of the fingers and loss of hand function. The disease is common in men older than 40 years; in persons of Northern European descent; and in persons who smoke, use alcohol, or have diabetes mellitus. The symptoms of Dupuytren's contracture are often mild and painless and do not require treatment. Patients present with a small, pitted nodule (or multiple nodules) on the palm, and may stay the same for months or years. In some patients, however, it may progress to the next stage, in which cords of fibrous tissue form in the palm and run into the fingers or thumb, eventually, pulling them into a permanently flexed position, making it difficult to perform activities of daily living.
The disease initially can be managed with observation and non-surgical therapy. It will regress without treatment in about 10 % of patients. Injection of steroids into the nodule has been shown to reduce the need for surgery. Surgical referral should be made when metacarpophalangeal (MCP) joint contracture reaches 30 degrees or when proximal interphalangeal (PIP) joint contracture occurs at any degree. In-office percutaneous needle aponeurotomy is an alternative to surgery (Trojian and Chu, 2007).
Intralesional Steroid Injection
Ball and colleagues (2016) Dupuytren's disease is a common fibrotic disorder of the palm characterized by the development of progressive flexion deformities in the digits, leading to significant functional impairment. Surgical excision remains the most common treatment. However, this is only indicated in patients with established contractures rather than those with early disease. Early disease is generally characterized by the presence of palmar nodules with limited or no contracture of the fingers. The ideal treatment would be directed at patients with early progressive disease to prevent future deterioration. Various non-surgical treatment modalities have been described but there is currently no systematic assessment of the role and effectiveness of these treatments in patients with early disease. Using a PICOS analysis, these investigators reviewed publications of studies of patients with early disease who had received physical therapies, pharmacological treatment, or radiotherapy. Following PRISMA guidelines titles and abstract were screened using pre-defined criteria to identify those reporting outcomes specifically relating to the treatment of early disease. In the absence of a definition of early disease studies were included if early Dupuytren's disease (DD) was described clinically, with digital contractures not exceeding 30°, Tubiana grades N to 1, and which reported identifiable data. Studies were excluded if data for early Dupuytren's disease patients could not be extracted for analysis. In this systematic review, a total of 26 studies were identified and analyzed to evaluate the effect of pharmacological therapy (n = 11), physical therapy (n = 5) and radiotherapy (n = 10) on early Dupuytren's disease. The studies comprised 20 case series, 1 cohort study with the remainder reporting case studies. All publications were graded level of evidence IV or V assessed using the Oxford Centre for Evidence Based Medicine grading. Narrative descriptions of the data were presented. The authors concluded that physical therapies were the most robustly assessed, using objective measures but the studies were under-powered, providing insufficient evidence of efficacy. Intralesional steroid injection and radiotherapy appeared to lead to softening of nodules and to retard disease progression, but lacked rigorous evaluation and studies were poorly designed. These researchers stated that there is an urgent need for adequately powered, double-blinded, randomized trials for this common disorder which affects 4 % of the population.
An UpToDate review on “Dupuytren's contracture” (Aggarwal and Blazar, 2017) states that "[i]ntralesional glucocorticoid injection with triamcinolone acetonide and lidocaine hydrochloride may be helpful if local tenderness is bothersome (eg, the patient develops tenosynovitis) or if the palmar nodule is growing rapidly. ....Glucocorticoid injection is helpful in patients with more recent disease onset; cords with or without significant contracture do not respond to glucocorticoid injection." Regarding use of glucocorticoids as a treatment for flexion contractures, the review stated that “[o]ther interventions, including continuous slow skeletal traction, dimethyl sulfoxide, vitamin E, allopurinol, physical therapy, ultrasound therapy, glucocorticoid injections, interferon, and splinting, have generally not been successful.”
Management of Recurrent Dupuytren's Contracture
Wong et al (2022) stated that with numerous treatment modalities available, it is unclear if the treatment of recurrent Dupuytren disease is as effective as its initial treatment. These investigators examined the outcomes of management of recurrent DC. Adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, Medline, Embase, PubMed, CINAHL, and Cochrane Central Register of Controlled Trials were searched from their inception to April 2020. Studies of patients aged 18 years or older undergoing treatment for recurrent DC were included. The risk of bias in non-randomized studies of interventions tool was used for quality assessment. This systematic review identified 12 studies: 311 patients with 224 affected digits-index (n = 5; 2.2 %), long (n = 17; 7.6 %), ring (n = 57; 25.4 %), small (n = 112; 50 %), and unspecified (n = 33; 14.7 %); of these, there were 76 MCP joints (45.5 %), 90 PIP joints (53.9 %), and 1 distal interphalangeal (DIP) joint (0.6 %). Previous treatment included the following: percutaneous needle aponeurotomy (n = 103 of 311 patients; 33.1 %), collagenase clostridium histolyticum-injection (CCH; n = 75 of 311; 24.1 %), limited fasciectomy (LF) ± skin graft (n = 83 of 311; 26.7 %), fasciotomy (n = 1 of 311; 0.3 %), and unspecified (n = 64 of 311; 20.6 %). Recurrence was treated by percutaneous needle aponeurotomy (n = 68 of 311 patients; 21.9 %); CCH injection (n = 53 of 311; 17.0 %); aponeurotomy or dermo-fasciectomy or LF (n = 176 of 311; 56.6 %); ray/digit amputation (n = 8 of 311; 2.6 %); and PIPJ arthrodesis (n = 6 of 293; 2.0 %); ROM was improved by 23.31° (95 % CI: 13.13° to 33.50°; I2 = 67 %; p = 0.05) and 15.49 ° (95 % CI: 2.67° to 28.31°; I2 = 76 %; p = 0.01) for MCPJ and PIPJ, respectively. The authors concluded that there is low level of evidence that both surgical and non-surgical treatments provided clinically important improvements for recurrent DC. These researchers stated that currently, the choice of treatment for recurrent disease remains a balance between both patient and physician preference. They stated that future steps should focus on consensus of a universal definition for recurrent DC to allow standardized comparison of treatments, complete outcome data reporting, as well as conducting higher level evidence studies to examine treatment effectiveness for recurrent DC.
The authors stated that this study had several drawbacks. First, the methodological quality of included studies ranged from low-to-moderate, indicating a moderate risk of bias in the results. Second, the generalizability of the outcomes is inherently limited given the lack of universal definition for recurrence. Without a clinical definition, it is difficult to determine the effect of baseline differences in patients, which are an important factor in surgeons’ discretion for treatment . Third, there is inconsistency in outcomes reported across studies. This posed as a barrier when results were pooled for meta-analysis. Fourth, length of follow-up was variable across studies; with insufficient follow-up, secondary recurrences, ROM, and contracture could not be accurately documented. Finally, the meta-analysis combined outcomes of both surgical and conservative modalities without subgroup analysis within each group. The heterogeneous nature of this analysis made it difficult to compare if specific modalities of treatments within each group were superior or non-inferior. For instance, despite surgery being effective for improving ROM for patients with DC, it is not possible to comment if limited fasciectomy or fasciotomy would provide better results. As such, only a general impression of outcomes of treating recurrent DC can be made.
Percutaneous Needle Aponeurotomy
Another treatment of Dupuytren's contracture (DC) is injection of steroids into the nodule; and has been shown to reduce the need for surgery. Surgical referral should be made when MCP joint contracture reaches 30 degrees or when PIP joint contracture occurs at any degree. In-office percutaneous needle aponeurotomy is an alternative to surgery (Trojian and Chu, 2007).
Manet and associates (2011) stated that DC is a retractile fibrosis of the superficial palmar aponeurosis of the hand, resulting in a progressive and fixed flexion of the fingers that may result in severe limitation of hand function. It affects several millions of people in Europe and North America. Risk factors are genetic and sometimes related to mellitus diabetes. There is no spontaneous remission. Until recently, surgery was the only treatment, but now needle aponeurotomy emerges as a therapeutic alternative. It should be performed as first-line treatment by a trained practitioner. Short-term and long-term results of needle aponeurotomy appear identical to those of surgery, with milder complications. It is indicated in palmar, palmo-digital, as well as in strictly digital forms of the disorder.
In a review on percutaneous needle aponeurotomy, Foucher and colleagues (2003) reviewed the charts of 211 patients treated consecutively on 261 hands and 311 fingers to assess the rate of post-operative complications. The first 100 patients were evaluated with a mean follow-up of 3.2 years to assess the rate of recurrences and extension of the disease. In the whole group the mean age was 65 years and delay between onset and treatment was 6 years. Division of the cords were performed only in the palm in 165 cases, in the palm and finger in 111 and purely in the finger in 35. Complications were scarce without infection or tendon injury but 1 digital nerve was found injured during a second procedure. Post-operative gain was prominent at MCP joint level (79 % versus 65 % at interphalangeal level). The re-operation rate was 24 %. In the group assessed at 3.2 years follow-up, the recurrence rate was 58 % and disease "activity" 69 %. Fifty-nine hands need further surgery. The ideal indication for this simple and reliable technique is an elderly patient with a bowing cord and predominant MP contracture.
Cheng et al (2008) reviewed the safety and effectiveness of needle aponeurotomy for DC in Chinese patients. A total of 7 men and 1 woman aged 50 to 80 (mean of 67) years underwent needle aponeurotomy for DC. Five were manual workers and the other 3 were retired. Their chief complaints were difficulty moving the fingers, clumsiness of the hand, and occasional pain in the palm. No patient had any family history of DC. A total of 41 points were released in 13 fingers (3 middle, 3 ring, and 7 little). Immediately after release, the mean flexion contracture correction of the MCP and PIP joints were 50 (from 50 to 0) and 35 (from 46 to 11) degrees, respectively. At 22-month follow-up, the mean residual flexion contracture of both joints were 12 and 27 degrees; the corresponding long-term improvements were 70 and 41 %, respectively. No patient had a wound complication or neurovascular injury. All had a normal score for Disabilities of the Arm, Shoulder, and Hand. The authors concluded that for Chinese patients with DC, needle aponeurotomy is safe and effective. Long-term correction is better maintained in MCP than PIP joints (70 % versus 41 %).
Lellouche (2008) stated that DC or Dupuytren's disease of the hand is the retraction of the palmar aponeurosis. Its course is progressive and leads to an irreducible flexion deformity of one or more fingers. Early diagnosis is necessary for the table test, which determines the need for treatment. Needle aponeurotomy should be the first option treatment. This minimally invasive out-patient procedure minimizes sick leave and does not require immobilization or physical therapy. Several studies confirmed the short-term and intermediate-term effectiveness of this treatment and the minimal side effects when performed by experienced operators. Multiple procedures for extensive disease (several knots) can be performed in the hospital. Close medical and surgical collaboration is necessary for treatment of severe forms, treatment failures, and multiple recurrences.
Guidance from the National Institute for Clinical Excellence (NICE, 2004) concluded: "Current evidence on the safety and efficacy of needle fasciotomy for Dupuytren’s contracture appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance." The guidance explained that the main benefit offered by this procedure is a short-term reduction in the degree of contracture. The guidance stated that the evidence shows that the recurrence rate is approximately 50 % at 3 to 5 years and seems to depend on the severity of the disease. The guidance stated that some data suggest that individuals with less severe disease or with metacarpophalangeal joint contracture benefited most from this procedure.
- subtotal fasciectomy and
- infiltration with collagenase clostridium histolyticum (CCH) in regular clinical practice.
Observational, retrospective study based on data from the computerized clinical histories of 2 groups of patients:
- those treated surgically using a 1- or 2-digit subtotal fasciectomy technique (FSC) and
- those treated with CCH infiltration, monitored in regular clinical practice from February 2009 to May 2012.
Demographic (age, sex), clinical (number of digits affected and which ones) and use of resources (hospitalizations, medical visits, tests and drugs) data were collected. Resource use and associated costs, according to the hospital's accounting department, were compared based on the type of treatment from Spain's National Health Service. A total of 91 patients (48 (52.8 %) in the FSC group) were identified. The average age and number of digits affected was 65.9 (9.2) years and 1.33 (0.48) digits affected in the FSC group, and 65.1 (9.7) years and 1.16 (0.4) digits in the CCH group. Overall, the costs of treating DC with subtotal FSC amount to €1,814 for major ambulatory surgery and €1,961 with hospital stay including admission, surgical intervention (€904), examinations, dressings and physiotherapy. As to collagenase infiltration, costs amount to €952 (including minor surgery admission, vial with product, office examination and dressings). Finally, comparing total costs for treatments, a savings of €388 is estimated in favor of CCH treatment in the best-case scenario (patient under MAS system with no need for physiotherapy) and €1,008 in the worst-case scenario (patient admitted to hospital needing subsequent physiotherapy), implying a savings of 29 % and 51 %, respectively. The authors concluded that this study demonstrated that treating patients with DC by injection with CCH generated a total savings of 29 % and 51 % (€388 and €1008) compared with fasciectomy at the time of treatment. Moreover, they stated that long-term evolution of CCH treatment is uncertain and the recurrence rate unknown.
In a retrospective cohort study, Atroshi et al (2014) compared CCH injections and FSC for DC regarding actual total direct treatment costs and short-term outcomes. Patients aged 65 years or older with previously untreated DC of 30° or greater in the MCP and/or PIP joints of the small, ring or middle finger were included in this study. The CCH group comprised 16 consecutive patients treated during the first 6 months following the introduction of CCH as treatment for DC at the study center. The controls were 16 patients randomly selected among those operated on with FSC at the same center during the preceding 3 years. Treatment with CCH was given during 2 standard outpatient clinic visits (injection of 0.9 mg, distributed at multiple sites in a palpable cord, and next-day finger extension under local anesthesia) followed by night-time splinting. Fasciectomy was carried out in the operating room (day surgery) under general or regional anesthesia using standard technique, followed by therapy and splinting. Outcome measures included actual total direct costs (salaries of all medical personnel involved in care, medications, materials and other relevant costs), and total MCP and PIP extension deficit (degrees) measured by hand therapists at 6 to 12 weeks after the treatment. Collagenase injection required fewer hospital outpatient visits to a therapist and nurse than FSC. Total treatment cost for CCH injection was US$1,418.04 and for FSC US$2,102.56. The post-treatment median (IQR) total extension deficit was 10 (0 to 30) for the CCH group and 10 (0 to 34) for the FSC group. The authors concluded that treatment of DC with 1 CCH injection cost 33 % less than FSC with equivalent effectiveness at 6 weeks regarding reduction in contracture.
Radiotherapy
Prophylactic external beam radiation therapy (RT) has been reported to prevent disease progression in early-stage DC.
Keilholz et al (1996) evaluated initial response, long-term outcome, as well as treatment toxicity of RT for the prevention of disease progression in early-stage DC. A total of 96 patients (142 hands) received ortho-voltage RT, which consisted of 2 courses with daily fractionation of 5 x 3 Gy (total dose of 30 Gy) separated by a 6-week interval. The extent of disease was staged according to the Tubiana's classification. Initial evaluation was performed 3 months after completion of RT; long-term outcome was analyzed at last follow-up. The mean follow-up was 6 +/- 2 (range of 1 to 12) years. Fifty-seven patients with a minimum follow-up of 5 (median 7.5; mean of 9.5 to 12) years were separately evaluated for long-term outcome (i.e., prevention of disease progression). Acute and late treatment toxicity was assessed using the Radiation Therapy Oncology Group/EORTC criteria. According to stage, 130 cases (92 %) remained stable at 3 months follow-up, 10 improved (7 %), and 2 progressed (1 %). An objective reduction of symptomatic cords and nodules was achieved in 107 cases (75 %) at 3 months follow-up. Moreover, 87 % of the patients reported a subjective relief of symptoms. In long-term follow-up, only 16 of 142 cases (11 %) had progressed according to stage. In the group with minimum follow-up 5 years (n = 57), 44 patients (77 %) experienced no disease progression, whereas 13 progressed (23 %) inside [8 cases (14 %)] or outside [5 cases (9 %)] of the RT field. Most failures could have been avoided with appropriate choice of larger safety margins included in the treated portals; however, the failures outside were still amenable for another RT course. The authors concluded that RT is effective to prevent disease progression for early-stage DC, which helps to avoid an otherwise necessary surgical procedure that is performed in advanced stages of DC.
Seegenschmiedt et al (2001) presented the 1-year results of a prospective randomized trial that compared two different RT dose concepts for early-stage DC. A total of 129 patients (62 females; 67 males) were entered in this study: 69 had bilateral and 60 unilateral involvement of DC accounting for 198 irradiated hands. According to Tubiana's classification, 73 hands had Stage N (nodules/cords, no extension deficit = flexion deformity), 61 had Stage N/I (less than or equal to 10 degrees deficit), 59 had Stage I (11 to 45 degrees deficit), and 5 had Stage II (46 to 90 degrees deficit) DC. Prophylactic RT was randomly delivered; in Group A, 63 patients (95 hands) received 10 x 3 Gy (total dose of 30 Gy) in 2 series (5 x 3 Gy) separated by 8 weeks; in Group B, 66 patients (103 hands) received 7 x 3 Gy (total dose of 21 Gy) in 1 series within 2 weeks. Ortho-voltage RT (120 kV) was applied using standard cones and individual shielding of un-involved areas of the palm. Relevant patient and disease parameters were equally distributed in both groups. Evaluation (toxicity, efficacy) was performed at 3 and 12 months after RT. Subjective (patient's opinion) and objective parameters (measurements, palpation, and comparative photographs) were applied to assess treatment response. Minimum follow-up was 1 year. Acute toxicity was minimal, but slightly more pronounced in Group B. Seventy-six (38 %) hands developed skin reactions common toxicity criteria [CTC] 1 degrees (A, 30; B, 46); and 12 (6 %) had skin reactions CTC 2 degrees (A, 4; B, 8). Chronic side effects were limited to dryness, desquamation, skin atrophy, and change of sensation (LENT 1 degrees ) in 9 (5 %) sites without differences between the two groups. At 3 and 12 months after RT, subjective and objective reduction of symptoms, nodules, and cords occurred in both groups (p < 0.01) with no differences between the groups: in Group A, 55 (56 %) sites regressed, 35 (37 %) remained stable, and 7 (7 %) progressed, whereas in Group B, 55 (53 %) regressed, 39 (38 %) remained stable, and 9 (9 %) progressed at 12-month follow-yp (non-significant). Overall and mean number of nodules, cords, and skin changes decreased at 3 and 12 months. The "treatment failure" rate at 1 year was 16 of 198 (8 %), but only 4 (2 %) sites required hand surgery for disease progression. Seven of 60 patients with unilateral DC received prophylactic RT for the initially un-involved, contralateral hand due to progression of DC. The authors concluded that both prophylactic RT concepts have been well-accepted and well-tolerated by patients. Within the first year, they were equally effective to prevent further disease progression of DC and obtain considerable symptomatic improvement. Although 1-year results suggested similar response rates for both treatment groups, long-term follow-up of greater than 5 years has to be awaited for final assessment and recommendation of an optimized RT treatment schedule.
In a retrospective analysis, Betz et al (2010) reported the long-term outcome and late toxicity of RT to prevent disease progression in patients with early-stage DC. A total of 135 patients (208 hands) were irradiated with ortho-voltage (120 kV; 20 mA; 4-mm Al filter) in 2 courses with 5 daily fractions of 3.0 Gy to a total dose of 30 Gy; separated by a 6- to 8-week interval. The extent of disease was described according to a modified Tubiana's classification. Long-term outcome was analyzed at last follow-up with a median follow-up of 13 years (range of 2 to 25 years). Late treatment toxicity and objective reduction of symptoms as change in stage and numbers of nodules and cords were evaluated and used as evidence to assess treatment response. According to the individual stages, 123 cases (59 %) remained stable, 20 (10 %) improved, and 65 (31 %) progressed. In stage N 87 % and in stage N/I 70 % remained stable or even regressed. In more advanced stages, the rate of disease progression increased to 62 % (stage I) or 86 % (stage II). A total of 66 % of the patients showed a long-term relief of symptoms (i.e., burning sensations, itching and scratching, pressure and tension). Radiotherapy did not increase the complication rate after surgery in case of disease progression and only minor late toxicity (dry desquamation, skin atrophy) could be observed in 32 % of the patients. There was no evidence for a second malignancy induced by RT. The authors concluded that after a mean follow-up of 13 years, RT is effective in prevention of disease progression and improves patients' symptoms in early-stage DC (stage N, N/I). In case of disease progression after RT, a "salvage" operation is still feasible.
In a systematic review, Kadhum and colleagues (2017) examined the evidence on the use of radiotherapy in Dupuytren's disease. Only 6 articles met a minimum set standard, 5 of which were retrospective cohort studies and 1 a RCT. A total of 770 Dupuytren's hands, nearly all with Tubiana stage 0 to 1 disease, were irradiated with an average 30 Gy. Disease regression ranged from 0 % to 56 %, stability from 14 % to 98 % and progression from 2 % to 86 %. Salvage surgery was successful in all cases of disease progression post-radiotherapy. There were no reports of adverse wound healing problems associated with such surgery or radiotherapy-associated malignancy. The authors concluded that radiotherapy should be considered an unproven treatment for early Dupuytren's disease due to a scarce evidence base and unknown long-term adverse effects. They stated that well-designed RCTs are needed to confirm the benefits of radiotherapy treatment.
An UpToDate review on “Dupuytren's contracture” (Aggarwal and Blazar, 2017) states that “Prophylactic external beam radiation therapy can prevent progression and can provide symptomatic benefit in patients with mild to moderate flexion deformities; however, no controlled studies have been published”.
Guidance from the National Institute for Health and Care Excellence (NICE, 2016) concluded that "[t]he evidence on radiation therapy for early Dupuytren's disease raises no major safety concerns. Current evidence on its efficacy is inadequate in quantity and quality, and is difficult to interpret because of uncertainty about the natural history of Dupuytren's disease."
Investigational Therapies
An UpToDate review on “Dupuytren's contracture” (Aggarwal and Blazar, 2019) states that “Other interventions, including continuous slow skeletal traction … ultrasound therapy, interferon, and splinting, have generally not been successful”.
Anti-Tumor Necrosis Factor Therapy
Nanchahal and colleagues (2018) noted that Dupuytren's disease is a common fibrotic condition of the hand that causes irreversible flexion contractures of the fingers, with no approved therapy for early stage disease; their previous analysis of surgically-excised tissue defined tumor necrosis factor (TNF) as a potential therapeutic target. In a randomized, dose-response, proof-of-concept, phase-IIa clinical trial, these researchers examined the efficacy of injecting nodules of Dupuytren's disease with a TNF inhibitor. Patients were randomized to receive adalimumab on 1 occasion in dose cohorts of 15 mg in 0.3 ml, 35 mg in 0.7 ml, or 40 mg in 0.4 ml, or an equivalent volume of placebo in a 3:1 ratio. Two weeks later the injected tissue was surgically excised and analyzed. The primary outcome measure was levels of mRNA expression for α-smooth muscle actin (ACTA2). Secondary outcomes included levels of α-SMA and collagen proteins. A total of 28 patients were recruited, 8 assigned to the 15-mg, 12 to the 35-mg and 8 to the 40-mg adalimumab cohorts. There was no change in mRNA levels for ACTA2, COL1A1, COL3A1 and CDH11. Levels of α-SMA protein expression in patients treated with 40-mg adalimumab (1.09 ± 0.09 ng per μg of total protein) were significantly lower (p = 0.006) compared to placebo treated patients (1.51 ± 0.09 ng/μg). The levels of procollagen type I protein expression were also significantly lower (p < 0.019) in the sub-group treated with 40-mg adalimumab (474 ± 84 pg/μg total protein) compared with placebo (817 ± 78 pg/μg). There were 2 serious AEs, both considered unrelated to the study drug. The authors concluded that in this dose-ranging study, injection of 40-mg of adalimumab in 0.4 ml resulted in down-regulation of the myofibroblast phenotype as evidenced by reduction in expression of α-SMA and type I procollagen proteins at 2 weeks. These data formed the basis of an ongoing phase-IIb clinical trial (n = 138) assessing the efficacy of intra-nodular injection of 40-mg adalimumab in 0.4 ml compared to an equivalent volume of placebo in patients with early stage Dupuytren's disease.
Autologous Fat Grafting
Tuncel and co-workers (2017) described their experience with treating Dupuytren's disease (DD) (17 patients; 18 hands) using needle aponeurotomy and non-centrifuged autologous fat grafting. Patients were treated with needle aponeurotomy and non-centrifuged autologous fat graft under general anesthesia. The fat grafts were injected into the surgical area so as to stay in contact with the operated site. An extension splint was used for 1 week post-operatively and the patients received hand therapy for 3 weeks. Before the treatment, the contracture in the proximal interphalangeal and metacarpophalangeal joints was a mean of 45.06 ± 13.44 degrees and 36.56 ± 13.09 degrees, respectively. It was 1.61 ± 1.65 and -0.56 ± 3.78 degrees at 3 months, respectively. The difference between these measurements was statistically significant. The mean follow-up period was 12 months. The results were satisfactory and no complications were observed during the follow-up period. The authors concluded that percutaneous aponeurotomy with non-centrifuged autologous fat grafting was found to have significantly beneficial effects in the treatment of DD. This was a small study (n = 17 patients); these preliminary findings need to be further validated.
Collagenase Nanocapsules
Villegas and associates (2018) noted that fibrosis is a common lesion in different pathologic diseases and defined by the excessive accumulation of collagen. Different approaches have been used to treat different conditions characterized by fibrosis. The FDA and EMA approved the use of collagenase to treat palmar fibromatosis (Dupuytren's contracture). The EMA approved additionally its use in severe Peyronie's disease, but it has been used off-label in other conditions. The approved treatment includes up to 3 (in palmar fibromatosis) or up to 8 (in penile fibromatosis) injections followed by finger extension or penile modeling procedures, typically causing severe pain. Frequent single injections are adequate to treat palmar fibromatosis. The need to repeatedly inject doses of this enzyme can be due to the labile nature of collagenase, which exhibits a complete activity loss after a short period of time.
Villegas, et al. (2018) presented a novel strategy to manage this enzyme based on the synthesis of polymeric nanocapsules that contain collagenase encapsulated within their matrix. These nanocapsules have been engineered for achieving a gradual release of the encapsulated enzyme for a longer time, which can be up to 10 days. The efficacy of these nanocapsules has been tested in a murine model of local dermal fibrosis, and the results demonstrated a reduction in fibrosis greater than that with the injection of free enzyme; this type of treatment showed a significant improvement compared to conventional therapy of free collagenase. The authors concluded that these findings indicated a high potential for this novel system to improve the current treatment for fibrotic diseases.
Combined Aponeurectomy and Peri-Operative 192-Ir High Dose Rate Brachytherapy for the Treatment of Dupuytren's Contracture
Ciernik and colleagues (2021) noted that partial aponeurectomy (PA) is a standard procedure for DC. These investigators reported a novel approach using surgery combined with peri-operative high dose rate (192-Ir HDR) brachytherapy. From March 2018 until February 2020, a total of 13 rays of 6 patients with DCs underwent PA followed by HDR brachytherapy. After removal of fibrous tissue and mobilization of the tendons, 1 to 3 catheters per patient were placed intra-operatively. Immediately after surgery, a planning computer tomography (CT) with 3D-planning was carried out. Thereafter, 10 to 12 Gy were administered to 0 to 2 mm from the catheters' surface and the catheters were removed 6 to 12 hours after brachytherapy. No complications were observed. The mean contractures were reduced from 55.4° (standard error [SE] 19.6) to 15.4° (SE 6.7; p < 0.01); 1 patient showed progressive fibrosis of a non-treated ray during follow-up. The authors concluded that HDR brachytherapy in combination with surgery was feasible and harbors the potential for combined modality therapy to reduce relapse rates of advanced or relapsing DC. Moreover, these researchers stated that controlled studies are needed to examine the role of bi-modal therapy compared with PA alone.
Cryopreserved Placental Membrane
Dress and Tassis (2018) noted that DD is a rare connective tissue disorder resulting in progressive fibrosis and thickening of the palmar fascia, and contracture of the fingers due to excessive collagen deposition. Staged surgical interventions are reserved for severe cases, yet worsening of fibrosis and contracture of fingers post-surgery, has been reported to have a recurrence rate as high as 85 %.
Dress and Tassis (2018) reported on the use of viable cryopreserved placental membrane (vCPM) allograft as an adjunct to open fasciectomy. In a patient with debilitating bilateral DD contractures of more than 20 years duration, this novel approach resulted in a 34.8 % ROM improvement and ability to fully extend all digits of the right hand. No adverse events (AEs) were recorded. At 1 year post-surgery, the patient had no decrease in ROM. The authors concluded that these findings indicated that vCPM incorporation in open fasciectomy may provide benefit in reducing contracture recurrence in DD patients. Moreover, they stated that long-term follow-up data are needed to provide additional insight on the utilization and clinical outcomes of vCPM in surgical fasciectomies.
Dynamic Manugraphy for Evaluation of the Outcome of Aponeurectomy in Patients with Dupuytren's Contracture
Garkisch and colleagues (2021) stated that DCs interfere with physiological gripping. While limited aponeurectomy is an accepted treatment modality to restore finger mobility, methods to objectify functional outcome beyond determination of the ROM are scarce. This study included patients with DC being scheduled for unilateral limited aponeurectomy. Clinical data were gathered prospectively by chart review and interview. The DASH-score and flexion contracture for fingers were registered before surgery, 3, and 6 months following surgery. At the same time, dynamic manugraphy for simultaneous recording of the grip pattern and forces generated by the affected hand and anatomic areas (i.e., thumb, index finger, middle finger, ring finger, little finger and palm) were carried out. All findings obtained during the follow-up period were compared to the situation at baseline. Comparison between paired samples was performed using Wilcoxon rank test. All p values were 2-sided and p < 0.05 was considered to be significant. Out of 23 consecutively enrolled patients, 19 (15 men, 4 women) completed follow-up examinations. Manugraphy confirmed the impairment of physiological gripping with concomitant pathological load distribution at base line. Limited aponeurectomy significantly reduced flexion contractures; however, the DASH-score remained at an excellent level in 1 patient, indicated improvement in 11 and worsening in 7 patients; 6 patients had lower grip force at t6 compared to the pre-operative condition, although the pre-operative flexion contracture (greater than or equal to 110°) was considerably improved in all of them. In 4 of those, the DASH-score improved while it turned worse in 2 of them. The force of surgically treated fingers remained unchanged in t3 patients while it was improved and worsened in 50 % of the remaining patients, respectively. Manugraphy revealed physiological gripping by enlargement of contact area and higher force transmission by the fingertips in 10 of 12 patients with constant or even improved DASH-score and in 3 of 7 patients with a worsened DASH-score. The authors concluded that evaluating the reduction of flexion contracture and grip force alone was insufficient to comprehensively reflect the functional outcome of aponeurectomy for DC. Visualizing physiological grip pattern provided an additional tool to objectify the success of surgical treatment. These researchers stated that dynamic manugraphy is a promising tool to evaluate the outcome of limited aponeurectomy in patients with DC.
Middle-Phalanx Excision and Ligament Reconstruction
Eiriksdottir and Atroshi (2019) stated that recurrent severe DC of the small finger's PIP joint is a difficult problem. Further surgery carries high risk of complications and poor outcome. Patients are often offered finger amputation. These researchers have devised a novel surgical procedure consisting of middle phalanx mono-block resection and ligament reconstruction to create a new functioning inter-phalangeal joint. Two patients requesting small-finger amputation because of severe PIP joint contracture after multiple treatments for DC were offered and accepted this new procedure. Through a dorsal incision the extensor tendon was incised longitudinally exposing the middle phalanx and inter-phalangeal joints. The collateral ligaments of both inter-phalangeal joints were detached from the middle phalanx. The middle phalanx was dissected from soft tissues (including the flexor digitorum superficialis tendon) and removed. The distal phalanx was brought proximally and the ends of the collateral ligaments were sutured with non-absorbable sutures with the joint held in full extension and congruency. The 2 patients were evaluated at 18 months and 15 months after surgery, respectively. Both patients regained good finger posture with almost full extension and had normal sensation and no pain. Active flexion in the new inter-phalangeal joint was 60 degrees and 35 degrees, respectively. Both patients had full MCP joint flexion and extension, normal 2-point discrimination in the small finger and higher grip strength in the treated than the contralateral hand. Radiographs showed a congruent new inter-phalangeal joint. Both patients were very satisfied with the outcome. The authors concluded that in patients with DC and severe PIP joint contracture after multiple treatments, this novel procedure consisting of middle-phalanx excision and ligament reconstruction creating a new functioning inter-phalangeal joint had good short-term outcomes and is a favorable alternative to finger amputation. Moreover, these researchers stated that longer follow-up will show whether these results are durable. Furthermore, longer follow-up can show whether the patients develop symptomatic osteoarthritis (OA) in the new inter-phalangeal joint.
Night Orthosis
In a multi-center, open, randomized controlled trial, Jerosch-Herold et al (2011) evaluated the effect of night splinting on self-reported function, finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy for Dupuytren's contracture. A total of 154 patients from 5 regional hospitals were randomized after surgery to receive hand therapy only (n = 77) or hand therapy with night-splinting (n = 77). Primary outcome was self-reported function using the DASH questionnaire. Secondary outcomes were finger range of motion and patient satisfaction. Primary analysis was by intention-to-treat. A total of 148 (96 %) patients completed follow-up at 12 months. No statistically significant differences were observed on the DASH questionnaire (0 to 100 scale: adjusted mean diff. 0.66, 95 % CI: - 2.79 to 4.11, p = 0.703), total extension deficit of operated digits (degrees: adjusted mean diff 5.11, 95 % CI: -2.33 to 12.55, p = 0.172) or patient satisfaction (0 to 10 numerical rating scale: adjusted mean diff -0.35, 95 % CI: -1.04 to 0.34, p = 0.315) at 1 year post surgery. Similarly, in a secondary per protocol analysis no statistically significant differences were observed between the groups in any of the outcomes. The authors concluded that no differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving hand therapy and only splinted if and when contractures occurred. Given the added expense of therapists' time, thermoplastic materials and the potential inconvenience to patients having to wear a device, the routine addition of night-time splinting for all patients after fasciectomy or dermofasciectomy is not recommended except where extension deficits re-occur.
In a pilot study, Kemler and colleagues (2012) evaluated the effectiveness of post-operative splinting after limited fasciectomy for Dupuytren's disease. A total of 54 patients with a PIP joint flexion contractures of at least 30° were randomized to receive either a 3-month splinting protocol together with hand therapy under the direct supervision of hand therapists, or the same hand therapy alone. Extension deficit of the PIP joint (primary outcome measure), global perceived effect, pain intensity, comfort and complications were assessed at baseline and 1 year after surgery. In an intention-to-treat analysis, the group assigned to splint-plus-hand therapy had a mean reduction of 21° in flexion contracture after 1 year, compared with 29° in the group receiving hand therapy alone (p = 0.1). There was no difference between the groups regarding other parameters. After operative release of a Dupuytren's contracture, a post-operative protocol using a splint and hand therapy was no better than hand therapy alone in minimizing post-operative flexion contractures.
In a single-center RCT, Collis et al (2013) examined the effectiveness of night extension orthoses on finger range of motion and hand function for 3 months following surgical release of Dupuytren contracture. These researchers also determined how well finger extension was maintained in the total sample. They randomized 56 patients to receive a night extension orthosis plus hand therapy (n = 26) or hand therapy alone (n = 30). The primary outcome was total active extension of the operated fingers (degrees). Secondary outcomes were total active flexion of the operated fingers (degrees), active distal palmar crease (cm), grip strength (kg), and self-reported hand function using the Disabilities of the Arm, Shoulder, and Hand questionnaire (0 to 100 scale). There were no statistically significant differences between the no-orthosis and orthosis groups for total active extension or for any of the secondary outcomes. Between the first post-operative measure and 3 months after surgery, 62 % of little fingers had maintained or improved total active extension. The authors concluded that the use of a night extension orthosis in combination with standard hand therapy has no greater effect on maintaining finger extension than hand therapy alone in the 3 months following surgical release of Dupuytren contracture. These findings indicated that the practice of providing every patient with a night extension orthosis following surgical release of Dupuytren contracture may not be justified except for cases in which extension loss occurs after surgery. They stated that their results also challenged clinicians to research ways of maintaining finger extension in a greater number of patients.
Samargandi and colleagues (2017) examined the role of night orthosis use after surgical correction of Dupuytren's contracture. These investigators searched Medline, Embase, CINAHL, AMED, OTSeeker, and CENTRAL for articles published from inception of the databases to August 2015. Assessment was undertaken by 2 independent reviewers. Methodological quality of RCTs was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa instrument. A total of 7 studies met the standard for inclusion in this review; 659 patients across these 7 studies were included in the analysis, with follow-up ranging from 3 to 72 months. None of the included studies assessed recurrence. The analysis revealed no significant improvement in range of motion (ROM) of hand joints for patients who received a static night orthosis after Dupuytren surgery compared with patients without an orthosis. Similarly, no differences were found in patient-reported functional status across the 2 groups. The authors concluded that the current literature does not appear to support the use of static night orthosis in addition to hand therapy after surgical correction of Dupuytren contracture.
Bowers et al (2021) stated that current prescribing information for the treatment of patients with DC with injectable CCH recommends use of a night extension orthosis for 4 months after treatment. In a single-center study, these investigators examined if this treatment would improve the outcomes. Adult patients with DC treated with CCH during the study period were eligible for inclusion. Subjects were randomized to orthosis or no orthosis groups and were stratified based on the severity of contracture before randomization. The orthosis group was fitted post-manipulation with a hand-based custom orthosis that held the treated finger in maximal comfortable extension, and subjects were instructed to wear the orthosis at night for 3 months. They were assessed at 7 to 10 days, 30 days, and 90 days post-manipulation. Orthosis compliance was measured with a survey. The primary outcome measure was improvement in TAE, defined as the sum of active MCP, PIP, and DIP joint extension in the treated finger at 90 days after treatment. Secondary outcomes included total active flexion (TAF), Michigan Hand Questionnaire scores, patient satisfaction, and clinical success. A total of 26 patients completed the study, 12 in the orthosis group and 14 in the no orthosis group. The majority of contractures (90 %) were primarily through the MCP joint. Subjects in both groups showed significant improvements in TAE at 90-day follow-up (orthosis, p = 0.002; no orthosis, p = 0.001). The difference in improvement in the median TAE between the 2 groups was not significant (p = 0.40). There were no significant differences between groups for TAE, TAF, Michigan Hand Questionnaire scores, patient satisfaction, or clinical success at any of the time-points assessed (p > 0.05). The authors concluded that in patients with DC with primarily MCP joint involvement, providing an orthosis after treatment with CCH may not offer a short-term benefit compared with CCH treatment alone in terms of TAE, TAF, or patient-reported outcome measures. These researchers stated that future studies are needed to examine the role of night orthosis use in larger, more heterogenous populations at longer time-points; nevertheless, the findings of this study questioned the short-term benefit of night-time orthosis use following CCH treatment. Level of Evidence = I.
Percutaneous Needle Aponeurotomy in Combination with Lipografting
Hovius and colleagues (2011) described a novel minimally invasive alternative for Dupuytren disease and its outcome. The procedure consists of an extensive percutaneous aponeurotomy that completely disintegrates the cord and separates it from the dermis. Subsequently, the resultant loosened structure is grafted with autologous lipo-aspirate. After 1 week of post-operative extension splinting, patients are allowed normal hand use and are advised to use night splints for 3 to 6 months. These investigators treated and reported on their experience with 91 patients (99 hands) operated on in Miami and Rotterdam; from 50 patients, the authors reported on goniometry (average follow-up of 44 weeks). The contracture from the PIP joint improved significantly from 61 degrees to 27 degrees, and contracture from the MCP joint improved from 37 degrees to -5 degrees; 94 % of patients returned to normal use of the hand within 2 to 4 weeks and 95 % were very satisfied with the result. No new scars were added, and a supple palmar fat pad was mostly restored. Complications were digital nerve injury in 1 patient, post-operative wound infection in 1 patient, and complex regional pain syndrome in 4 patients. The authors concluded that this new minimally invasive technique shortens recovery time, adds to the deficient subcutaneous fat, and leads to scarless supple skin. By its ability to treat multiple rays, it addresses the abnormality in the entire hand. The procedure is safe and effective, especially for primary cases. Moreover, they stated that comparative prospective randomized studies are currently in process to fully determine the role of percutaneous aponeurotomy plus lipografting in the treatment of Dupuytren contracture.
Tuncel and colleagues (2017) described their experience with treating Dupuytren's disease using needle aponeurotomy and non-centrifuged autologous fat grafting. The study included 17 patients (18 hands). Patients were treated with needle aponeurotomy and non-centrifuged autologous fat graft under general anesthesia. The fat grafts were injected into the surgical area so as to stay in contact with the operated site. An extension splint was used for 1 week post-operatively and the patients received hand therapy for 3 weeks. Before the treatment, the contracture in the PIP and MCP joints was a mean of 45.06 ± 13.44 degrees and 36.56 ± 13.09 degrees, respectively. It was 1.61 ± 1.65 and -0.56 ± 3.78 degrees at 3 months, respectively. The difference between these measurements was statistically significant. The mean follow-up period was 12 months. The results were satisfactory and no complications were observed during the follow-up period. The authors concluded that based on the results of the study, percutaneous aponeurotomy with non-centrifuged autologous fat grafting was found to have significantly beneficial effects in the treatment of Dupuytren's disease. These preliminary findings from a small (n = 17 subjects) study need to be validated by well-designed studies.
Radial Extracorporeal Shock Wave Therapy
Knobloch et al (2011) noted that Dupuytren's disease is a progressive disease due to unknown causal agents or genetics. An epidemiological analysis of 566 cases in North Germany estimated that around 1.9 million Germans are suffering from Dupuytren's disease. Beside Dupuytren's disease, there are a number of further less common forms of progressive fibromatosis, such as knuckle pads, plantar fibromatosis or Peyronie's disease. Surgery in plantar fasciectomy yields to a 60 % recurrence rate depending on the extent of the plantar fasciectomy. Peyronie's disease of the penis affects middle-aged men between 40 and 60 years with penile pain, curvature during erection and potential erectile dysfunction. In a randomized controlled trial (RCT) in Peyronie's disease 2,000 focused extracorporeal shock waves reduced pain significantly and improved erectile function and quality of life. These researchers hypothesize that focused extracorporeal shock wave therapy (ESWT) is able to reduce Dupuytren's contracture. Given the fact that recurrence rate in Dupuytren's disease is high und unpredictable, ESWT as a non-invasive tool might be applicable both, in primary and secondary prevention of the progression as well as for treatment. As such, these investigators have planned a RCT studying the effect of high-energy focused ESWT on patients suffering Dupuytren's disease with patient-related outcome measures such as the Disabilities of the Arm, Shoulder and Hand (DASH) score and the Michigan Hand Outcome Questionnaire as primary outcome parameters.
Brunelli and colleagues (2020) noted that while the effectiveness of focused ESWT in the treatment of DC is supported by 1 positive trial, the effects of radial ESWT is unclear. This case-report described a 79-year old man with a 4-year history of impairment of left-hand function and pain due to DC with weakness and flexion deformities of middle and ring fingers. He has not been treated before for this impairment. The diagnosis of DC was based on clinical features and US images; treatment was 4 weekly sessions of radial ESWT with 1,400 impulses 3 bar each, 12-Hz. The limitations in activities of daily living (ADL) were analyzed via the DASH and Michigan Hand Outcome Questionnaire (MHQ) at baseline, after 4 sessions of radial ESWT and at 4-months follow-up. Data analysis showed a significant reduction of hand deformities and an improvement of ADL performance. The effects continued at the 4-months follow-up. The authors concluded that this case report demonstrated the feasibility of radial ESWT. Radial ESWT sessions may be performed by a physiotherapist in outpatient clinics with cost reduction compared with surgical treatment and focused ESWT. Radial ESWT is a non-invasive, well-tolerated therapy, so it should be considered in the treatment of DC. Moreover, these researchers stated that further studies, including RCTs, are needed to examine the effectiveness of radial ESWT in DC and its comparable effects to focused ESWT.
Taheri et al (2022) examined the effect of shock wave therapy on the improvement of symptoms and function of patients with DC. This research was a pre-post intervention study, carried out in patients referred to the physical medicine clinics of Isfahan during 2019 to 2020. Subjects experienced shock wave therapy for 6 sessions, each in a week, and improvement of symptoms and function were assessed and compared after the period of study and follow-up (before treatment, 6 weeks after treatment, and 14 weeks after treatment). The pain VAS and disabilities of the arm shoulder and hand questionnaire were completed for all patients at the mentioned time, and the finger contraction angle was also measured by a goniometer over these intervals. A total of 20 patients, 11 (55 %) men and 9 (45 %) women participated in the study. The mean and standard deviation (SD) of their age was 66.6 ± 7.11 years. The trend of pain severity of patients was continuously and significantly decreasing up to 14 weeks, which implied the effectiveness of the intervention (p < 0.05). Moreover, subjects' functional status improved due to the continuation of the intervention, and its trend was decreasing up to 14 weeks (p < 0.05). As for the contraction angle, there was a continuous and significant decreasing trend until week 14, and the intervention was also effective on the contraction angle (p < 0.05). The authors concluded that shock wave therapy could be effective in improving the symptoms and function of patients with DC. Moreover, these researchers stated that more comprehensive studies with larger sample sizes and long-term follow-up are needed to ascertain the effects of shock wave therapy for the treatment of DC.
The authors stated that the non-referral of patients for follow-up was one of the limitations of this study, which could be solved by sufficient explanation to patients and appropriate and regular follow-up. Another limitation of this study was the lack of funding, which it tried to overcome by reducing costs as much as possible. Furthermore, these investigators tried to reduce the design costs, as much as possible, in order to collect the least sample size and to achieve proper internal and external validity.
Sorafenib for the Treatment of Dupuytren Disease
Schoenfeld et al (2022) noted that palmar and plantar fibromatosis are benign proliferative processes that present as a diffuse thickening or nodules of the hands and/or feet, and may lead to flexion contractures, pain, and functional impairment known as DC and Ledderhose disease, respectively. Current treatments are non-curative and associated with significant morbidity. In a case-series study, these investigators reported on the outcomes of 5 patients with advanced disease (non-surgical candidates) treated with sorafenib, which exhibited an expected safety profile. All 5 patients reported objective responses as evaluated by a decrease in tumor size and/or tumor cellularity from baseline; and all 5 participants reported subjective pain relief and/or functional improvement. Mechanistically, immunohistochemistry revealed patchy positivity for PDGFRβ, a known target of sorafenib. The authors concluded that the outcomes of these 5 patients suggested the safety and effectiveness of a relatively well-tolerated oral agent in the treatment of DC and Ledderhose disease and suggested the need for future controlled studies.
Tension and Compression Orthoses
In a randomized study, Brauns and colleagues (2017) determined how much improvement 2 types of orthotic device (tension and compression) as only treatment intervention can provide on a Dupuytren's contracture. Is a compression orthosis better than a tension orthosis? A total of 30 patients with measurable flexion contractures of the fingers were identified. Both primary and recurrence cases were included. Patients were randomized in 2 groups of 15 patients: one group had a standard tension orthosis (Levame), and the other group a newly designed silicon compression orthotic device. Patients were instructed to wear the orthotic devices 20 hours a day during 3-month study period. Data were collected at 1st visit and after 3 months of orthotic treatment. Primary outcomes were active extension deficit of each joint and total active extension (TAE) of the digit; secondary outcome was patient satisfaction. Visual analog scale (VAS) score of function and esthetics (0 to 10 points) were recorded at the start and after 3 months. Flexion contracture was reduced at least 5 degrees in all patients. After 3 months, TAE was significantly reduced in both groups (both p < 0.001). The mean change in TAE was 32.36° in the tension group and 46.47° in the compression group. Although reduction of TAE deficit was bigger in the compression group, this difference was not statistically significant (p = 0.39); VAS scale of esthetics and functionality was significantly increased in both treatment groups. The functional VAS scale after 3 months was 11 % higher in the compression group than in the tension group (p = 0.03). A major complication of a tension orthotic is skin ulcers. The authors concluded that tension and compression orthotic devices can be used as a non-operative treatment of Dupuytren's disease in both early proliferative untreated hands and aggressive post-surgery recurrence. Moreover, they stated that although there is no statistically significant difference, compression orthoses appeared to be more effective and are better-tolerated; nevertheless, adjustment of orthotic design and research on long-term results are needed.
Collagenase Injection versus Limited Fasciectomy Surgery for the Treatment of Dupuytren's Contracture
Dias et al (2024) stated that Dupuytren's contracture is caused by nodules and cords which pull the fingers towards the palm of the hand. Treatments include limited fasciectomy surgery, collagenase injection, and needle fasciotomy. There is limited evidence comparing limited fasciectomy with collagenase injection. In a unblinded, randomised-controlled, non-inferiority, 2-arm study with a cost-effectiveness evaluation and nested qualitative and photographic sub-studies, these researchers examined if collagenase injection is not inferior to limited fasciectomy for the treatment of Dupuytren's contracture. This trial included 31 National Health Service hospitals in England and Scotland. Participants included patients with Dupuytren's contracture of 30 degrees or greater who had not received previous treatment in the same digit. Collagenase injection with manipulation 1 to 7 days later was compared with limited fasciectomy. The primary outcome was the Patient Evaluation Measure score, with 1 year after treatment serving as the primary end-point. A difference of 6 points in the primary end-point was used as the non-inferiority margin. Secondary outcomes included: Unité Rhumatologique des Affections de la Main scale; Michigan Hand Outcomes Questionnaire (MHQ); recurrence; extension deficit and total active movement; further care/re-intervention; complications; quality-adjusted life-year (QALY); resource use; as well as time to function recovery. These researchers applied online central randomization, stratified by the most affected joint, and with variable block sizes allocates participants 1:1 to collagenase or limited fasciectomy. Participants and clinicians were not blind to treatment allocation. Between July 31, 2017 and September 28, 2021, a total of 672 participants were recruited (n = 336 per group), of which 599 participants contributed to the primary outcome analysis (n = 285 limited fasciectomy; n = 314 collagenase). At 1 year (primary end-point) there was little evidence to support rejection of the hypothesis that collagenase is inferior to limited fasciectomy. The difference in Patient Evaluation Measure score at 1 year was 5.95 (95 % CI: 3.12 to 8.77; p = 0.49), increasing to 7.18 (95 % CI: 4.18 to 10.88) at 2 years. The collagenase group had more complications (n = 267, 0.82 per participant) than the limited fasciectomy group (n = 177, 0.60 per participant), but limited fasciectomy participants had a greater proportion of “moderate”/”severe” complications (5 % versus 2 %). At least 54 participants (15.7 %) had contracture recurrence and there was weak evidence suggesting that collagenase participants recurred more often than limited fasciectomy participants (odds ratio [OR] 1.39, 95 % CI: 0.74 to 2.63). At 1 year, collagenase had an insignificantly worse QALY gain (-0.003, 95 % CI: -0.006 to 0.0004) and a significant cost saving (-£1,090, 95 % CI: -£1,139 to -£1,042) than limited fasciectomy with the probability of collagenase being cost-effective exceeding 99 % at willingness to pay thresholds of £20,000 to £30,000 per QALY. At 2 years, collagenase was both significantly less effective (-0.048, 95 % CI: -0.055 to -0.040) and less costly (-£1,212, 95 % CI: -£1,276 to -£1,147). The probability of collagenase being cost-effective was 72 % at the £20,000 threshold but limited fasciectomy became the optimal treatment at thresholds over £25,488. The Markov model found the probability of collagenase being cost-effective at the life-time horizon dropped below 22 % at thresholds over £20,000. Semi-structured qualitative interviews found that those treated with collagenase considered the outcome to be acceptable, although not perfect. The photography sub-study found poor agreement between goniometry and both participant and clinician taken photographs, even after accounting for systematic differences from each method. The authors concluded that among adults with Dupuytren's contracture, collagenase delivered in an outpatient setting was less effective but more cost-saving than limited fasciectomy. Moreover, these researchers stated that further investigations are needed to establish the longer-term implications of both treatments.
These investigators noted that impacts of the COVID-19 pandemic resulted in longer waits for Dupuytren's contracture treatment, meaning some participants could not be followed-up for 2 years. This resulted in potential under-estimation of Dupuytren's contracture recurrence and/or re-intervention rates, which may particularly have impacted the clinical effectiveness and long-term Markov model findings. These researchers stated that recurrence and re-intervention usually occur after 1 year; thus, follow-up to 5 years or more could resolve whether the differences observed in the Dupuytren's interventions surgery versus collagenase trial to 2 years worsen.
Dermofasciectomy for the Treatment of Dupuytren Disease
Hozack and Rayan (2023) stated that revision procedures for recurrent Dupuytren disease (DD) could be difficult and carry a high risk of complications. In a single-center, single-surgeon study, these investigators described surgical strategies used for cases of recurrence and reported on their outcomes. They reviewed operative cases for recurrent DD; prior procedures entailed collagenase injection, percutaneous needle fasciotomy, or open surgical fasciectomy in the same digit or area of the hand. From January 1981 to December 2020, a total of 54 procedures were carried out on 33 patients for recurrent DD. Most patients were men (82 %), had bilateral involvement (64 %) and family history (52 %), and some had ectopic disease in their feet (24 %). The small finger was involved in 76 % of the cases, and the PIP joint was involved in 83 % of these digits. The procedures included 38 partial fasciectomies (72 %), 12 dermofasciectomies (23 %), 3 radical fasciectomies (6 %), 1 of each needle fasciotomy, ray amputation, and PIP joint arthrodesis (2 %); and 23 patients (43 %) required full thickness skin grafts with an average area of 7.1 cm2 (range of 1 to 20 cm2). These researchers noted that dermofasciectomy is usually indicated for recurrent cases when the skin is adherent to the diseased tissue and should be excised with the disease cords. This will leave skin shortage that requires full thickness skin grafting. The authors concluded that the findings of this study highlighted the complexity of recurrent DD case management and found the treatment required for 95 % of patients in this series was open partial fasciectomy with or without demofasciectomy. Full thickness skin grafting was necessary in nearly 50 % of the cases.
Khaliq and Orji (2024) provided an in-depth review of the available evidence of Dupuytren's contracture and its management. The underlying mechanisms entail complex cellular processes, especially the role of transforming growth factor-beta (TGF-β) in promoting fibroblast activity and collagen buildup. Treatment strategies depend on the severity of the condition; non-surgical options like collagenase injections and needle aponeurotomy are effective for early stages but often have high recurrence rates. For more advanced cases, surgical options such as limited and radical fasciectomy are considered, aiming to restore finger extension while addressing potential complications. Challenges in management include high recurrence rates and variability in disease progression, emphasizing the need for standardized assessment protocols and innovative therapeutic approaches. These researchers noted that dermofasciectomy is another surgical option that involves removing both the affected fascia and the overlying skin. After the excision, a skin graft is used to cover the resulting defect. This procedure is generally reserved for cases with significant skin involvement or where there is an increased concern regarding recurrence, as it has been shown to lower the likelihood of contracture recurrence. However, dermofasciectomy is more complex than standard fasciectomy, resulting in a longer recovery time and a greater risk of complications, including graft failure and infection. The authors concluded that this review underscored the importance of early diagnosis and intervention to preserve hand function and enhance quality of life (QOL). It calls for ongoing research into targeted therapies to reduce recurrence rates.
Pandya et al (2025) examined the long-term effectiveness of dermofasciectomy in patients with advanced Dupuytren disease over a 20-year period. These researchers carried out a longitudinal analysis on patients with advanced Dupuytren disease treated with dermofasciectomy. Disease severity, surgical techniques, rates of PIP joint contracture recurrences, disease recurrence, wound complications, as well as post-operative care protocols were systematically recorded and analyzed. A total of 281 cases were reviewed, with patients undergoing dermofasciectomy for advanced Dupuytren disease. Full-thickness skin graft loss occurred in 1.1 % of cases, with partial loss in 4.2 %, mainly in diabetic patients. Junctional recurrence was observed in 3.1 % of cases, with no recurrence under the graft itself. Functional outcomes were favorable, with 97 % of patients reporting improved hand function. Nerve damage was minimal, with transient neuropraxia in 2.8 % and only 1 case (0.4 %) of persistent sensory loss. The authors concluded that dermofasciectomy appeared to be an effective surgical intervention for advanced Dupuytren disease, offering substantial long-term benefits in terms of function and disease control. These investigators stated that these findings underscored the effectiveness and durability of dermofasciectomy in managing advanced cases, especially with appropriate post-operative care. Level of Evidence = IIb.
Furthermore, an UpToDate review on “Dupuytren's contracture” (Aggarwal and Blazar, 2025) states that “The specific surgical technique used depends upon the individual characteristics of the patient and upon the preferences of the surgeon. More aggressive techniques such as radical fasciectomy or dermofasciectomy do not appear to offer an advantage over limited fasciectomies”.
Digit Widget for the Treatment of Proximal Inter-Phalangeal (PIP) Flexion Contractures
Craft et al (2011) noted that checkrein ligament release for treatment of PIP joint Dupuytren contractures does not address the shortened arteries or deficient skin. The Digit Widget, an external fixation device, uses soft-tissue distraction to overcome these issues. These researchers compared checkrein ligament release after fasciectomy versus preliminary soft-tissue distraction, followed by operative release, for treatment of PIP joint Dupuytren contractures. They compared operative and post-operative characteristics of patients treated with either fasciectomy plus checkrein ligament release or Digit Widget distraction between 2001 and 2008. A total of 17 patients (20 digits) underwent ligament release (mean contracture, 55.9 degrees); 6 of these 20 were re-operations; 13 patients (17 digits) underwent distraction (mean contracture, 67.6 degrees); 10 of 17 were re-operations. The 20 digits treated with fasciectomy plus ligament release had an average extension improvement of 31.4 degrees (range of -4 to 70 degrees). Digits treated with distraction had an average extension improvement of 53.4 degrees (range of 30 to 75 degrees) (p < 0.001 versus ligament release); 3 digits treated with distraction improved to full proximal inter-phalangeal extension. Initial contractures of 60 degrees or less treated by ligament release (n = 12) or distraction (n = 7) improved by means of 28.8 degrees and 47.7 degrees, respectively (p = 0.048). Contractures greater than 60 degrees treated by ligament release (n = 8) or distraction (n = 10) improved by means of 35.3 degrees and 57.3 degrees, respectively (p = 0.02). The authors concluded that soft-tissue distraction followed by operative release showed greater correction than Dupuytren fasciectomy plus checkrein ligament release. Moreover, these investigators stated that although the role of soft-tissue distraction in the treatment of Dupuytren contractures remains to be determined via ongoing RCTs and with longer follow-up, especially with regard to the potential for recurrence, their initial experience with the Digit Widget device has shown promise, especially for digits with severe contracture. Level of Evidence = III.
Agee and Goss (2012) stated that Dupuytren contracture of the PIP joint can be reversed by an extension torque transmitted from the Digit Widget by skeletal pins to the middle phalanx. This extension torque gradually restores length to soft tissues palmar to the PIP joint's axis of rotation. Simultaneously, tissues dorsal to the joint's axis will shorten toward normal length as the PIP progressively straightens. Although the contractile nodules and bands of Dupuytren disease may be excised either before or after reversal of the joint's contracture, a 2-staged approach is preferred: First, reverse the PIP flexion contracture, and second, excise the diseased tissue from the straightened finger. The authors believed this 2-staged approach yielded better results. Furthermore, it was technically easier to avoid injury to nerves and arteries while excising the nodules and bands, when one operates through palmar skin of more nearly normal length. The authors developed the Digit Widget; it is indicated for reversing PIP joint flexion contractures in which the etiology of the torque imbalance that created the contracture is known and the balance between flexion and extension torques can be returned to normal. Although Dupuytren disease remains the dominant etiology, other concomitant abnormalities that create force imbalance across the finger’s joints should be considered in a surgical plan designed to optimize restoration of active PIP extension. This study provided a single case on the use of the Digit Widget. These investigators noted that the Digit Widget should not be used for PIP joint contractures in which the anatomy of the joint or its cartilage surface is impaired as a result of arthritis or prior injury.
Murphy et al (2014) noted that surgery for Dupuytren's contracture used to be the only alternative of treatment. The past 5 years have seen the widespread adoption of minimally invasive treatments in the form of needle aponeurotomy and collagenase injection to disrupt the cords and restore ROM. Even newer and perhaps as effective treatments such as fat grafting and mechanical stretching with the Digit Widget may also end up being important tools of treatment.
Denkler et al (2021) stated that treatment of boutonniere Dupuytren disease is rare and is resistant to treatment because of altered tendon dynamics. These researchers used a small dose of collagenase clostridium histolyticum for an enzymatic tenotomy of the DIP joint and showed that hyper-extension at the DIP joint improved significantly. A total of 15 patients with boutonniere Dupuytren disease with severe PIP joint contractures averaging -69 degrees of extension were included in the study – 10 patients had at least 1 previous intervention, including surgical fasciectomy, Digit Widget treatment, and needle aponeurotomy. Collagenase clostridium histolyticum enzymatic tenotomy was carried out in-office as a wide-awake procedure. All subjects received varying doses of collagenase clostridium histolyticum for volar Dupuytren disease enzymatic fasciotomy and 0.1-mg of collagenase clostridium histolyticum into the distal extensor tendon for tenotomy to treat boutonniere deformity at the same time. Collagenase clostridium histolyticum enzymatic tenotomy significantly improved total active motion of the finger by 41.0 degrees (p = 0.001). Loss of extension at both the MCP joint and the PIP joint also improved with gains of 11.7 (p = 0.04) and 20.7 degrees (p = 0.0005) of extension, respectively. The average DIP joint hyper-extension improved from 29.7 degrees to 14.0 degrees (p = 0.002). The authors concluded that collagenase injection resulted in significant average improvement in joint contracture at all finger joints and significantly increased the arc of motion at the PIP joint and MCP joint. Although collagenase has been previously used for flexion contractures in Dupuytren disease, these researchers believed it has a role in the treatment of the DIP joint hyper-extension deformity associated with boutonniere deformity in Dupuytren disease as well. Level of Evidence = IV.
Qiu et al (2024) noted that the Digit Widget can be used to reverse PIPJ contractures in the hand. In a retrospective study, these researchers hypothesized that the use of the Digit Widget prior to fasciectomy in patients with severe Dupuytren's PIP contractures would result in short-term improvement and maintenance of the PIPJ contracture after fasciectomy. Patients who underwent placement of the Digit Widget soft tissue distractor before fasciectomy for Dupuytren's disease were identified between January 2015 and December 2018. Multiple fingers were considered separately. Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF), Pain Interference, and Depression scores were collected. Patients treated for contractures from etiologies other than Dupuytren's were not included. Multiple linear regression was used to compare initial PIP contractures, PF scores, and final contractures. There were 28 fingers in 24 patients with average age of 56 ± 12 years (range of 30.5 to 69.9 years). Initial mean PIPJ contracture was 81° (50° to 120°), which had corrected to 23° at time of removal. Average time between application and fasciectomy was 58 days (range of 28 to 112 days). At final follow-up, average of 449 days (range of 58 to 1,641 days), the average contracture was 39° (0° to 105°). Contracture immediately following fasciectomy was found to be strongly correlated with the contracture at final follow-up. There was no statistical relationship between final PROMIS PF scores and final change in contracture. The authors concluded that the Digit Widget external fixation device was effective for the correction of advanced PIPJ contractures related to Dupuytren's disease, with an average of 52 % improvement in contracture at 15 months.
The authors stated that this trial had several drawbacks. First, it was a retrospective study and contracture measurements were not precise. Second, some patients had involvements of MCPJs and PIPJs, whereas others had isolated PIPJ involvement, and some had multiple digits, whereas others had a single digit. Third, there was also a varying degree of contracture in the joints where the Digit Widget was used. Although this made interpretation of the data more complex, it was representative of the condition. Fourth, follow-up was limited (final follow-up -- average of 449 days); and given the reported risk of recurrent contracture, long-term follow-up is needed to examine if the early correction of the contracture is maintained and the development of recurrent disease. Fifth, it could be difficult to determine the cause of the PIP contracture and whether there was an intrinsic joint contracture along with the Dupuytren’s contracture; therefore, it was possible these patients could have had the same result with fasciectomy alone or fasciectomy and open PIPJ release. Ideally, these researchers would have a control group during this time with similar contractures treated solely with fasciectomy to compare the effectiveness of the Digit Widget. Sixth, these investigators began the collection of PROMIS scores in 2015; thus, not all participants had subjective outcomes to go along with the objective measurements.
Sono-Bath (Percutaneous Sonography-Guided Technique) for the Treatment of Dupuytren Contracture
Moungoundo et al (2025) noted that Dupuytren's contracture is a fibrotic disorder of the palmar fascia, resulting in debilitating finger deformities. Traditional treatments such as open fasciectomy and collagenase injection, carry high risks of complications and recurrence. Ultrasound (US)-guided techniques offer a potentially safer, minimally invasive alternative but are limited by the irregular skin surfaces and flexion deformities in Dupuytren's disease. The Sono-Bath, which immerses the hand in sterile liquid during the US-guided procedure, improves visualization and facilitates the use of cutting instruments. In this case-series report, 2 patients with Dupuytren's contracture were treated using the Sono-Bath. Under local anesthesia, the hand was immersed in sterile saline, allowing for enhanced sonographic imaging. The sterile liquid medium minimized tissue deformation and maintained a clear view of the pathological cords. Using the Sono-Bath, the surgeon was able to precisely position the US probe at a distance, improving visualization and access to the target area. Percutaneous release of the cords was carried out via small punctures, using specialized cutting instruments guided by real-time US, ensuring accurate and safe cord division. Both cases were successful, achieving full finger extension without complication. The Sono-Bath improved cord visualization and targeting, enabling safer and more effective procedures. Patients reported minimal discomfort. The authors concluded that the Sono-Bath may facilitate percutaneous US-guided treatment of Dupuytren disease using closed aponeurotomy at several levels. The technique is obviously contra-indicated when operating a recurrency. Moreover, these researchers stated that future investigations should entail RCTs to compare US-guided closed aponeurotomy with Sono-Bath with traditional techniques, examining long-term outcomes such as recurrence rates and functional improvement. In addition the Sono-Bath may have other applications in hand surgery such as foreign body removal and abscess drainage.
References
The above policy is based on the following references:
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