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Aetna Aetna
Clinical Policy Bulletin:
Total Hip Replacement
Number: 0287


Policy

Aetna considers Food and Drug Administration-approved metal-on-metal, metal-on-plastic, ceramic-on-plastic, or ceramic-on-ceramic total hip replacement prostheses medically necessary for total hip arthroplasty (see Appendix for selection criteria).

Aetna considers minimally invasive total hip arthroplasty a medically necessary acceptable alternative to conventional total hip arthroplasty.

Aetna considers removal and revision surgery due to post total hip replacement (THR) metallosis alone, without evidence of loosening or malposition, experimental and investigational because there is insufficient clinical evidence in the published peer-reviewed medical literature.

See also CPB 0661 - Hip and Shoulder Resurfacing.



Background

Previously, most total hip prostheses utilize an acetabular cup either lined with polyethylene or composed entirely of polyethylene articulating against a cobalt-chromium-molybdenum (CoCr) or ceramic femoral head.  Serious problems affecting the outcome of total joint replacement with these types of prostheses have been extensive and progressive peri-prosthetic osteolysis and aseptic loosening, which may result in revision, even though the components are still well fixed and functioning.  Polyethylene particulate debris generated from metal-on-polyethylene bearing surfaces and the resulting biologic response to this debris are thought to be largely responsible.

In recent years, there has been renewed interest in metal-on-metal bearing surfaces for total joint arthroplasty.  This is especially true in younger and more active patients who face the possibility of multiple revision procedures during their lifetime.  In the long-term, the second-generation all-metal prostheses have demonstrated lower friction and wear rates than metal-on-polyethylene bearing surfaces.  Recent studies reported that the second-generation metal-on-metal hip replacement prostheses exhibit a lower rate of acetabular revision and loosening than did those with previous metal-on-metal designs and that they had no more acetabular loosening or osteolysis than did those with metal-on-polyethylene articulations for follow-up periods of 5 to 10 years.

Another alternative to standard polyethylene is alumina-on-alumina ceramic.  When comparing hard-on-hard bearings, the ceramic-on-ceramic coupling has several theoretical advantages over metal-on-metal.  Because of the ceramic's extremely low coefficient of friction and its potential for superior wear resistance, these couples promise both wear rates that are appreciably less than polyethylene-on-metal and metal-on-metal couples.

Available literature indicates that alumina-on-alumina ceramic couplings are a viable alternative to metal-on-polyethylene designs.  The combination of new high quality ceramic acetabular and femoral bearing heads with hip systems that have achieved long-term stable fixation can result in a substantial increase in the longevity of fixation for implants especially in the younger and more active patients.

Available studies of metal-on-metal and ceramic-on-ceramic total hip implants primarily involve cohorts of younger, more active patients.  The chief advantage of these hip implants over standard metal-on-polyethylene hip implants is their greater longevity.  There is no adequate evidence that metal-on-metal or ceramic-on-ceramic total hip implants offer clinically significant benefits over standard metal-on-polyethylene hip implants for older patients.

Bhandari et al (2005) reported a meta-analysis of 6 randomized controlled studies suggested that bisphosphonates have a beneficial effect with regard to maintaining more peri-prosthetic bone mineral density than that in controls.  However, the limitations of the available studies and the lack of analyses of clinically relevant outcomes (e.g., functional outcomes, revision rates, and quality of life) necessitate the planning and conduct of a sufficiently sized, methodologically sound trial with clinically relevant end points.  Until this has been done, the current evidence regarding the beneficial effects of bisphosphonates on peri-prosthetic bone following total joint (e.g., knee and hip) arthroplasty should be interpreted with caution.

A technology assessment of hip implants by the Institute for Clinical Effectiveness and Health Policy (Augustovsky et al, 2006) found that the clinical trials comparing ceramic against conventional prostheses found no significant differences in the revision rate among the different types of prostheses.  In case series of patients with the ceramic prosthesis, reported revision rates at 10 years were less than 10 %, which is considered within acceptable limits and comparable to those reported for conventional prostheses.  Similar results have been reported for metal-on-metal hip prostheses, where randomized controlled trials with follow-up up to 5 years found no differences between metal-on-metal and conventional prostheses in effectiveness and complication rates (Augustovsky et al, 2006).  The assessment noted that, although there are some reports of an increase in cancer in persons with metal-on-metal hip prostheses, there are other reports evaluating metal-on-metal prostheses with follow-up up to 28 years that have found no increase in the incidence of any cancer.  The assessment stated that no study comparing ceramic prosthesis with metal-on metal prosthesis was found.  The assessment concluded that, although interim results with both the ceramic and metal-on-metal prostheses are promising, available studies have found no significant differences in revision rates during follow-up periods of 10 to 15 years.  The assessment stated that, because the advantages of these materials may be observed at longer terms, their potential benefits would be greatest for younger patients (under 50 years of age) (Augustovsky et al, 2006).

In a meta-analysis, Smith and colleagues (2010) compared the clinical and radiological outcomes and complication rates of hip resurfacing (HRS) and total hip arthroplasty (THA).  A systematic review was undertaken of all published (Medline, CINAHL, AMED, EMBASE) and unpublished or gray literature research databases up to January 2010.  Clinical and radiological outcomes as well as complications of HRS were compared to those of THA using risk ratio, mean difference, and standardized mean difference statistics.  Studies were critically appraised using the CASP appraisal tool.  A total of 46 studies were identified from 1,124 citations.  These included 3,799 HRSs and 3,282 THAs.  On meta-analysis, functional outcomes for subjects following HRS were better than or the same as for subjects with a THA, but there were statistically significantly greater incidences of heterotopic ossification, aseptic loosening, and revision surgery with HRS compared to THA.  The evidence base showed a number of methodological inadequacies such as the limited use of power calculations and poor or absent blinding of both patients and assessors, possibly giving rise to assessor bias.  The authors concluded that on the basis of the current evidence base, HRS may have better functional outcomes than THA, but the increased risks of heterotopic ossification, aseptic loosening, and revision surgery following HRS indicate that THA is superior in terms of implant survival.

Garbuz and associates (2010) conducted a prospective randomized clinical trial to compare clinical outcomes of resurfacing versus large-head metal-on-metal THA.  These researchers randomized 107 patients deemed eligible for resurfacing arthroplasty to have either resurfacing or standard THA.  Patients were assessed for quality-of-life outcomes using the PAT-5D index, WOMAC, SF-36, and UCLA activity score.  The minimum follow-up was 0.8 years (mean of 1.1 years; range of 0.8 to 2.2 years).  Of the 73 patients followed at least 1 year, both groups reported improvement in quality of life on all outcome measures.  There was no difference in quality of life between the 2 arms in the study.  Serum levels of cobalt and chromium were measured in a subset of 30 patients.  In both groups cobalt and chromium was elevated compared to baseline.  Patients receiving a large-head metal-on-metal total hip had elevated ion levels compared to the resurfacing arm of the study.  At 1 year, the median serum cobalt increased 46-fold from baseline in patients in the large-head total hip group, while the median serum chromium increased 10-fold.  At 1 year, serum cobalt was 10-fold higher and serum chromium 2.6-fold higher than in the resurfacing arm.  Due to these excessively high metal ion levels, the authors recommended against further use of this particular large-head THA.

Appendix

Selection Criteria for Metal-on-Metal or Ceramic-on-Ceramic Total Hip Replacement:

  1. Member with diseases/conditions of the hip that cause chronic pain and functional impairment; e.g.,

    1. Arthritis secondary to acetabular fracture; or
    2. Arthritis secondary to traumatic dislocation or fracture-dislocation; or
    3. Avascular necrosis (osteonecrosis): Age less than or equal to 70, severe pain and functional impairment; or
    4. Fracture (e.g., acetabular fracture and displaced fracture of the femoral neck): Displaced fracture and bone quality deficient; or
    5. Degenerative joint disease (e.g., osteoarthritis): Age less than or equal to 70, moderate/severe pain and severe functional impairment; or
    6. Primary and secondary tumors involving the proximal femur; or
    7. Revision (e.g., failed previous hip fracture fixation and revision of hip arthrodesis): Age less than or equal to 70, moderate pain and functional impairment;

    and

  2. Conservative measures such as weight loss, anti-inflammatory medication, reasonable restriction of activity, and use of a cane have failed; and
  3. Member is not allergic to components of the implant (e.g., cobalt, chromium or alumina).

Contraindications for Total Hip Replacement:

Total hip replacement is considered experimental and investigational for persons with one or more of the following contraindications to total hip replacement:

  • Active infection of the hip joint or any other regions; or
  • An absence or relative insufficiency of the abductor musculature; or
  • Any process that is rapidly destroying bone; or neurotrophic arthritis; or
  • Any unstable medical conditions that would significantly increase the risk of morbidity or mortality (e.g., cardiac, pulmonary, liver, genitourinary, or metabolic disease; hypertension; and abnormal serum electrolyte levels); or
  • Inadequate bone stock inadequate to support the device; or
  • Multiple cysts (greater than 1 cm) of the femoral head; or
  • Rapidly progressive neurological diseases; or
  • Severe osteopenia; or
  • Skeletal immaturity.
 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
27130
27132
27134
27137
27138
ICD-9 codes covered if selection criteria are met:
170.7 Malignant neoplasm of long bones of lower limb
198.5 Secondary malignant neoplasm of bone and bone marrow
715.15 Osteoarthrosis, localized, primary, pelvic region and thigh
715.25 Osteoarthrosis, localized, secondary, pelvic region and thigh
715.35 Osteoarthrosis, localized, not specified whether primary or secondary, pelvic region and thigh
716.15 Traumatic arthropathy pelvic region and thigh
733.14 Pathologic fracture of neck of femur (hip)
733.40 Aseptic necrosis of bone, site unspecified
733.42 Aseptic necrosis of bone, head and neck of femur
808.0 Fracture of acetabulum, closed
808.1 Fracture of acetabulum, open
820.00 - 820.9 Fracture of neck of femur
905.3 Late effects of fracture of neck of femur
996.40 - 996.48 Mechanical complication of internal orthopedic device, implant, and graft
V43.64 Joint replaced by other means, hip
ICD-9 codes not covered if selection criteria are met:
985.6 Toxic effect of Chromium [not covered for metallosis alone without evidence of loosening or malposition]
985.8 Toxic effect of other specified metals [not covered for metallosis alone without evidence of loosening or malposition]


The above policy is based on the following references:
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