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Clinical Policy Bulletin:
Ilizarov Method for Distraction Osteosynthesis
Number: 0220


Policy

  1. Aetna considers the Ilizarov method for distraction osteosynthesis medically necessary for members who meet both of the following selection criteria:

    1. Member has one of the following indications for the Ilizarov procedure:

      1. Limb length discrepancies with or without an associated deformity; or
      2. Bone defects with or without an associated deformity; or
      3. Angular/rotational deformities of the long bones; and

    2. Any of the following selection criteria is met:

      1. Member has a leg length discrepancy of more than 6 cm; or
      2. Member has an arm length discrepancy of more than 5 cm; or
      3. Member has a fracture of a long bone that has not healed in 6 or more months, and has tried and failed electrical stimulation (see CPB 343 - Bone Growth Stimulators) and bone grafting (see CPB 411 - Bone and Tendon Graft Substitutes and Adjuncts); or
      4. Member has an angular/rotational deformity of the long bones resulting in functional impairment, and has failed other treatments.

  2. Aetna considers the use of the Ilizarov method to correct short stature as cosmetic.

  3. Aetna considers the Ilizarov method experimental and investigational for all other indications.

Notes: Insertion of wires and subsequent osteotomy of the affected limb are performed in the hospital. Removal of the device can be performed in the office/clinic; thus, hospitalization to remove the device is not necessary.

See also CPB 549 - Distraction Osteogenesis for Craniofacial Defects.



Background

Distraction osteosynthesis refers to a technique in which a limb is gradually lengthened at a controlled rate across the osteotomy site.  The original limb lengthening procedure was first described in the English orthopedic literature by Codvilla (1905).  In the 1960s, the Wagner method (limb lengthening with cancellous bone grafting and plating of the distraction gap) was introduced into North America, and became the mainstay of limb lengthening in the United States for many years.  In this technique, an open mid-diaphyseal osteotomy is carried out across the periosteum, endosteum, and cortex resulting in a 0.5 to 1 cm diastasis; followed by the placement of an external fixation system secured by screws in both the proximal and distal metaphyses.  Distraction commences immediately following placement of the fixator.  The distraction rate is traditionally set at 1.5 to 2 mm per day.  Following attainment of the desired distraction length, iliac crest cancellous bone is grafted into the diastasis in a second operation.  The affected bone is plated, and the external distractor is removed.  The operated limb does not bear weight for an extended period of time to allow for incorporation of the graft.  In a third operation, the plate is removed, and the subject is put on protective weight bearing (Wagner, 1978; Hood and Riseborough, 1981).

A less invasive technique for distraction osteosynthesis was developed by a Russian orthopedist Gavriil Abramovich Ilizarov in the 1950s.  His work was introduced to Italy in the 1980s as a result of the former Soviet Union's policy of glasnost, and later to the United States (Frankel et al, 1988).  According to Ilizarov's principle of "tension stress", bone and soft tissue will heal and regenerate in a predictable fashion under tension.  The Ilizarov procedure comprises 4 phases: (i) corticotomy (a special type of percutaneous osteotomy) and placement of an external fixation system, (ii) latency period, (iii) distraction, and (iv) consolidation.  This method has been employed to treat a wide variety of bone defects including limb lengthening while correcting concurrent associated angular and rotational malalignments, transporting bone segments to fill fracture gaps, and healing non-union fractures.  Compared to other alternatives such as the Wagner technique, the Ilizarov method requires only one surgical procedure and appears to have fewer complications.  Additionally, the Ilizarov procedure allows for simultaneous correction of multiple deformities, early movement of adjacent joints, as well as early weight bearing (Do and Sadove, 1992; Simard et al, 1992).

Cattaneo et al (1993) described the use of the Ilizarov procedure to 97 humeri on 75 patients, with 68 lengthening in 46 patients (27 males and 19 females, average age of 16.5 years) and 29 treatments for non-union in 29 patients (17 males and 12 females, average age of 46 years).  For patients who underwent humeral lengthening, results were considered excellent if the projected lengthening was attained, or in the cases of length discrepancy, less than a 3-cm length discrepancy remained, or if axial alignment was acceptable (less than 10 degrees angulation), and scars were minimal.  Furthermore, pre-operative function had to be maintained.  Outcomes were deemed good if there was only minimal functional loss, and poor if there was a limb discrepancy of greater than 5 cm, angulation of more than 10 degrees and significant loss of function, or a permanent neurological injury.  For patients who had treatments for humeral nonunion, consolidation was considered an excellent result, whereas persistence or recurrence of nonunion was considered a poor result.  Duration of treatment ranged from 5 to 14 months.  Forty-two (91.3 %) of the 46 patients who had undergone humeral lengthening had excellent results, 3 (6.5 %) had good results, and the remaining 1 (2.2 %) had a poor result as a consequence of reduced shoulder motion.  There were no major complications associated with this procedure.  For patients who underwent treatments for humeral nonunion, 25 (86.2 %) of 29 humeri healed, and 4 (13.8 %) remained ununited.  Of these, there were 3 patients aged 55, 70, and 79 years, and 1 patient with irradiated bone.  Results of this study indicated that the Ilizarov procedure is effective in humeral lengthening as well as in the treatment of humeral non-union.

Cierny and Zorn (1994) compared conventional methods with the Ilizarov procedure in the treatment of 44 patients with segmental tibial defects.  Patients were divided into 2 groups: (i) 21 long bone defects (segmental defects averaged 6.5 cm) were reconstituted by means of transport (part of the Ilizarov procedure that entails sliding a bone fragment internally, producing distraction osteogenesis behind the defect until it is bridged) or distraction methodologies according to the Ilizarov technique, and (ii) 23 subjects (segmental defects averaged 8.5 cm) underwent conventional treatment of reconstruction using tissue transfers and transpositions, massive cancellous grafts, and combinations of internal and external fixation.  Total wound consolidation and infection arrest occurred after the first treatment in 71 % of the Ilizarov wounds, and 74 % of the conventionally treated wounds.  The major complication rate for the Ilizarov group was 33 %, while that for the conventionally treated group was 60 %.  The overall success rate (95 %) were the same for both groups.  However, the Ilizarov group averaged 9 fewer hours in the operating room, 23 fewer days in the hospital, 5 fewer months of disability times, and a saving of nearly $30,000 per application.  These findings indicated that the Ilizarov procedure is faster, safer, and less expensive approach than conventional methods for the treatment of segmental tibial defects.

Fadel and Hosny (2005) noted that the Taylor Spatial Frame (TSF) uses the slow correction principles of the Ilizarov system but adds a 6-axis deformity analysis incorporated within a computer program.  These researchers used the TSF in lengthening and deformity correction of the lower limbs to treat 22 cases from 1999 to 2001.  There were 14 females and 8 males (average age of 16.5 years).  Their target was lengthening in 8 cases, correction of deformities in 8 and both in 6.  The results were excellent in 18 cases, good in 2, and fair in 2.  Despite the cost, patient profile and a steep learning curve, the results were encouraging but less favorable than with the traditional Ilizarov external fixator.

Kristiansen et al (2006) noted that different methods and devices are used to perform lengthening and deformity reconstruction in the tibia.  Recently, the TSF has been introduced as a computer-assisted and versatile external ring fixator.  Lengthening index (LI) and complications are important result parameters, and the aim of this study was to review our first 20 tibial segments operated with the TSF and compared the results with those of using the traditional Ilizarov external fixator (IEF).  These researchers lengthened 20 tibial segments in 20 patients with the TSF.  The results were compared with those of 27 tibial segments from 27 patients that were lengthened with the IEF.  All segments were operated on with monofocal osteotomies.  In the over-lapping zone of comparable lengthening distances between 2.4 and 6.0 cm, the LI of 2.4 and 1.8 months/cm was not significantly different between the TSF and IEF groups, respectively (p = 0.17).  This non-significant difference was confirmed after adjustment for age.  The authors found no difference between the TSF and IEF frames regarding LI and complication rate.  However, rotational, translational, and residual deformity correction is easier to perform with the TSF.

Simpson et al (2008) stated that the TSF is a fixation device used to implement the Ilizarov method of bone deformity correction to gradually distract an osteotomized bone at regular intervals, according to a prescribed schedule.  These researchers modified conventional technique by: (a) pre-operatively planning a virtual three-dimensional (3D) correction; (b) basing the correction on the actual location of the frame with respect to the anatomy, immediately compensating for frame mounting errors; and (c) calculating the correction based on 3D CT data rather than measurements from radiographs.  They performed a laboratory study using plastic phantoms, and a pilot clinical study involving 5 patients.  In 20 tibial phantom experiments, these investigators achieved average correction errors of < 2 degrees total rotation and < 0.5 mm total lengthening.  They observed clinically acceptable corrections with no complications in this pilot clinical study.  The authors concluded that their method achieved high accuracy and precision in a laboratory setting, and produced acceptable outcomes in a pilot clinical study.

Naqui et al (2008) noted that correcting multi-planar lower-limb pediatric deformities requires complex and, in many cases, staged procedures.  The TSF is a sophisticated external fixator system that can be used to treat simple to complex multi-planar and multi-apical skeletal deformities.  These researchers described its use in 53 children during the last 7 years in a variety of pathologies and demonstrate its ease of use and versatility.  A review of medical and physiotherapy records, radiographs, and CT scans of all patients treated with a TSF between June 1999 and December 2005 at the Booth Hall Children's Hospital was conducted.  Data recorded were etiology of deformity, sex, age, number of previous operations, pre-operative deformity parameters, operative records and frame constructs, treatment regime, frame duration, follow-up protocol, post-treatment deformity, complications, and clinical and radiological outcome.  Fifty-three patients between the ages of 12 months and 16 years (mean of 10.7 years) underwent correction programs for 55 limbs (44 tibia and 11 femurs).  The etiology of deformity was congenital in 39 cases and acquired in 14.  These investigators were able to achieve an acceptable correction of deformity (leg length discrepancy < 15 mm, angulation < 5 degrees) in 52 limbs.  A number of complications were encountered.  The authors demonstrated the TSF's ease of use for both surgeon and patient and its versatility in a variety of pathologies.  The advantages of the TSF system are many.  It is a simple frame construct, and application is easy.  The plan and execution are structured with precise end points; it is a single-stage correction and thus avoids frame modifications.  Any residual deformity can be further corrected by use of the same frame.  The authors concluded  that the TSF is an effective and efficient way to correct a wide variety of simple and complex often obstinate pediatric limb deformities.

Marangoz et al (2008) stated that the TSF has been used commonly in children and young adults.  Its use in the tibia is more extensively studied and applied than in the femur. These researchers examined if normal alignment can be achieved with accuracy during correction of femoral deformities while avoiding major complications in children and young adults.  They retrospectively reviewed the clinical and radiographic records of 20 patients (22 limbs), aged 5.9 to 24.6 years, who underwent a TSF for femoral deformity.  Etiology included a number of diagnoses of the pediatric age.  Minimum follow-up was 4.5 months (mean of 15.7 months; range of 4.5-to 35 months).  The mean time in frame was 6.2 months (range of 2.6 to 19 months).  Frontal and sagittal plane deformities were corrected to within normal values.  A mean limb lengthening of 4.9 cm (range of 1.5 to 9 cm) was performed in 8 femora; 7 of which the limb length discrepancy was a secondary concern.  External fixation index in the lengthening subgroup was 2.2 months/cm.  The 15 complications in 13 limbs included pin tract infection, knee stiffness, delayed union, skin irritation, and posterior knee subluxation.  No complications occurred in 9 limbs.  Computer-assisted femoral deformity correction with 6-axis deformity analysis and the TSF is an accurate and safe technique in children and young adults.

McCarthy and colleagues (2008) examined if a monolateral fixator, which allows for correction of angular deformity and displacement in 3 planes, can correct lower extremity deformities to within normal radiographic means (anatomic lateral distal femoral angle, anatomic medial proximal tibial angle, and tibial femoral angle).  These researchers retrospectively reviewed the clinical records and radiographs of 22 consecutive patients (25 limbs) who underwent deformity correction using a new multi-axial monolateral external fixator.  The patients were 4 to 16 years of age.  The authors had a minimum 1.2-year follow-up (mean of 2.14 years; range of 1.2 to 3.1).  Those with primary femoral and tibial deformities had improvements in the mean deviation from normal of the anatomic lateral distal femoral angle, anatomic medial proximal tibial angle and tibial femoral angle.  Patients with Blount's disease had improvements in the mean anatomic medial proximal tibial angle from 59.9 masculine to 87.8 masculine.  Five patients had complications (2 pin site infections, 1 premature consolidation, 1 knee flexion contracture, 1 recurrence of varus).  Six patients developed secondary deformities, all of which were corrected using the primary or secondary hinge.  The authors concluded that this fixator can produce satisfactory results with relatively few complications.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
20690
20692
20693
20694
20696
20697
Other HCPCS codes related to the CPB:
E0747 Osteogenesis stimulator, electrical, noninvasive, other than spinal applications
G0283 Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care
ICD-9 codes covered if selection criteria are met:
733.81 - 733.82 Malunion or nonunion of fracture
736.31 - 736.42 Coxa valga or coxa vara (acquired), other acquired deformities of hip, genu valgum or genu varum (acquired),
736.70 Unspecified deformity of ankle and foot, acquired
736.81 Unequal leg length (acquired)
736.89 Other acquired deformities of other parts of limbs
754.40 - 754.44 Congenital genu recurvatum and bowing of long bones of leg
755.20 - 755.27 Reduction deformities of upper limb involving humerus, radius, and ulna
755.30 - 755.37 Reduction deformities of lower limb involving femur, tibia and fibula
755.61 - 755.64 Coxa valga or coxa vara, congenital, other congenital deformity of hip (joint), or congenital deformity of knee (joint)
755.69 Other anomalies of lower limb, including pelvic girdle [congenital angulation of the tibia]
ICD-9 codes not covered for indications listed in the CPB:
253.3 Pituitary dwarfism
259.4 Dwarfism, not elsewhere classified
756.4 Chondrodystrophy
783.40 Lack of expected normal physiological development in childhood
783.43 Short stature


The above policy is based on the following references:
  1. DiPasquale D, Ochsner MG, Kelly AM, Maloney DM. The Ilizarov method for complex fracture nonunions. J Trauma. 1994;37(4):629-634.
  2. Simard S, Marchant M, Mencio G. The Ilizarov procedure: Limb lengthening and its implications. Phys Ther. 1992;72(1):25-34.
  3. Cattaneo R, Catagni MA, Guerreschi F. Applications of the Ilizarov method in the humerus. Hand Clinics. 1993;9(4):729-739.
  4. Cierny III G, Zorn KE. Segmental tibial defects: Comparing conventional and Ilizarov methodologies. Clin Orthop Rel Res. 1994;301:118-123.
  5. Brown E. Distraction/compression osteosynthesis with the Ilizarov device. Diagnostic and Therapeutic Technology Assessment (DATTA). JAMA. 1992;268(19):2717-2724.
  6. Gugenheim JJ. The Ilizarov method. Orthopedic and soft tissue applications. Clin Plast Surg. 1998;25(4):567-578.
  7. Bianchi Maiocchi A. Historical review of the method according to Ilizarov. 15 years after its worldwide application. Bull Hosp Jt Dis. 1997;56(1):16-20.
  8. Pons JMV. Lengthening in achondroplasia [summary]. IN99003. Barcelona, Spain: Catalan Agency for Health Technology Assessment and Research (CAHTA); April 1999.
  9. Ng BK, Saleh M. Fibula pseudarthrosis revisited treatment with Ilizarov apparatus: Case report and review of the literature. J Pediatr Orthop B. 2001;10(3):234-237.
  10. Barbarossa V, Kucisec-Tepes N, Aldova E, et al. Ilizarov technique in the treatment of chronic osteomyelitis caused by Vibrio alginolyticus. Croat Med J. 2002;43(3):346-349.
  11. Garcia-Cimbrelo E, Marti-Gonzalez JC. Circular external fixation in tibial nonunions. Clin Orthop. 2004;(419):65-70.
  12. Birch JG, Samchukov ML. Use of the Ilizarov method to correct lower limb deformities in children and adolescents. J Am Acad Orthop Surg. 2004;12(3):144-154.
  13. Burns JK, Sullivan R. Correction of severe residual clubfoot deformity in adolescents with the Ilizarov technique. Foot Ankle Clin. 2004;9(3):571-582, ix.
  14. El-Mowafi H, Elalfi B, Wasfi K. Functional outcome following treatment of segmental skeletal defects of the forearm bones by Ilizarov application. Acta Orthop Belg. 2005;71(2):157-162.
  15. Codvilla A. On the means of lengthening in the lower limbs, the muscles, and the tissues which are shortened through deformity. Am J Orthop Surg. 1905;2:353-369.
  16. Wagner H. Operative lengthening of the femur. Clin Orthop Rel Res. 1978;136:125-142.
  17. Hood RW, Riseborough EJ. Lengthening of the lower extremity by the Wagner method: A review of the Boston Children's Hospital experience. J Bone Joint Surg [Am]. 1981;63(7):1122-1131.
  18. Frankel VH, Gold S, Golyakhovsky V. The Ilizarov technique. Bull Hosp Joint Dis Orthop Inst. 1988;48(1):17-27.
  19. Do H, Sadove RC. The Ilizarov method (callous distraction) in the treatment of open fractures of the tibia. J Ky Med Assoc. 1992;90(2):74-77.
  20. Paley D, Lamm BM, Katsenis D, et al. Treatment of malunion and nonunion at the site of an ankle fusion with the Ilizarov apparatus. Surgical technique. J Bone Joint Surg Am. 2006;88 Suppl 1 Pt 1:119-134.
  21. Rozbruch SR, Weitzman AM, Watson JT, et al. Simultaneous treatment of tibial bone and soft-tissue defects with the Ilizarov method. J Orthop Trauma. 2006;20(3):197-205.
  22. Brinker MR, O'Connor DP. Outcomes of tibial nonunion in older adults following treatment using the Ilizarov method. J Orthop Trauma. 2007;21(9):634-642.
  23. Peterson BM, McCarroll HR Jr, James MA. Distraction lengthening of the ulna in children with radial longitudinal deficiency. J Hand Surg [Am]. 2007;32(9):1402-1407.
  24. Fadel M, Hosny G. The Taylor spatial frame for deformity correction in the lower limbs. Int Orthop. 2005;29(2):125-129.
  25. Kristiansen LP, Steen H, Reikerås O. No difference in tibial lengthening index by use of Taylor spatial frame or Ilizarov external fixator. Acta Orthop. 2006;77(5):772-777.
  26. Simpson AL, Ma B, Slagel B, et al. Computer-assisted distraction osteogenesis by Ilizarov's method. Int J Med Robot. 2008;4(4):310-320.
  27. Naqui SZ, Thiryayi W, Foster A, et al. Correction of simple and complex pediatric deformities using the Taylor-Spatial Frame. J Pediatr Orthop. 2008;28(6):640-647.
  28. Marangoz S, Feldman DS, Sala DA, et al. Femoral deformity correction in children and young adults using Taylor Spatial Frame. Clin Orthop Relat Res. 2008;466(12):3018-3024.
  29. McCarthy JJ, Ranade A, Davidson RS. Pediatric deformity correction using a multiaxial correction fixator. Clin Orthop Relat Res. 2008;466(12):3011-3017.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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