Surgery Section - Total Hip Resurfacing

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Hip resurfacing can be categorized as partial hip resurfacing, in which a femoral shell is implanted over the femoral head, and total hip resurfacing, consisting of an acetabular and femoral shell. Partial hip resurfacing is considered a treatment option for avascular necrosis with collapse of the femoral head and preservation of the acetabulum. Total hip resurfacing, investigated in a broader range of patients including those with osteoarthritis, rheumatoid arthritis, and advanced avascular necrosis, may be considered an alternative to total hip arthroplasty, particularly in young active patients who would potentially outlive a total hip prosthesis. Therefore, total hip resurfacing could be viewed as a time-buying procedure to delay the need for a total hip arthroplasty. Proposed advantages of total hip resurfacing compared to total hip arthroplasty include preservation of the femoral neck and femoral canal, thus facilitating revision or conversion to a total hip replacement, if required. In addition, the resurfaced head is more similar in size to the normal femoral head, thus increasing the stability and decreasing the risk of dislocation compared to total hip arthroplasty. (2,3)

Total hip resurfacing has undergone various evolutions over the past several decades, with modifications in prosthetic design and composition and implantation techniques. For example, similar to total hip prostheses, the acetabular components of total hip resurfacing have been composed of polyethylene. However, over the years it has become apparent that device failure was frequently related to the inflammatory osteolytic reaction to debris wear particles. This problem is aggravated in surface replacements because the larger size of the femoral head compared to total hip prostheses increases the volume of debris wear particles.  The Buechel-Pappas Integrated Total Hip Replacement has been approved by the U.S. Food and drug Administration (FDA) for total hip resurfacing.  The weight-bearing surfaces composed of a ceramic femoral component and a polyethylene acetabular component. There has also been interest in metal-on-metal designs as a technique to reduce the debris wear particles.  The Conserve® Plus (Wright Medical Technology) is a metal-on-metal design that is currently undergoing investigation as part of the FDA approval process.  The trial includes 300 patients who will be followed up for a minimum of two years.  The Cormet Total Hip Resurfacing System (Corin) received 510(k) marketing clearance from the FDA on July 3, 2007.  However, the premarket approval information about the Cormet device has not yet been published on the FDA Web site.

In May 2006 the FDA granted premarket application (PMA) approval to the metal-on-metal Birmingham Hip Resurfacing (BHR) System (Smith and Nephew, Inc.) to use in patients requiring primary hip arthroplasty for non-inflammatory or inflammatory arthritis.  This decision was based primarily on a series of 2,385 patients who received this device by a single surgeon in England.  A number of post-approval requirements were agreed to including the following items:

• Study longer term safety and effectiveness through 10-year follow-up of the initial 350 patients in the patient cohort that was part of the PMA.
• Study the “learning curve” and the longer term safety and effectiveness of the BHR in the United States by studying 350 patients at up to eight sites where clinical and radiological data will be assessed annually through five years and at ten years.  Also, determine cobalt and chromium serum concentration and renal function in these patients at one, four, and ten years.
• Implement a training program to provide clinical updates to investigators.

In the PMA of the Birmingham device, the FDA listed several contraindications for total hip resurfacing. These contraindications include (not a complete listing) the following items:

• Bone stock inadequate to support the device due to:
  • Severe osteopenia or a family history of severe osteoporosis or severe osteopenia
  • steonecrosis or avascular necrosis with more than 50% involvement of the femoral head
  • Multiple cysts of the femoral head (more than 1 cm)
• Skeletal immaturity
• Vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery
• Known moderate to severe renal insufficiency
• Severely overweight
• Known or suspected metal sensitivity
• Immunosuppressed or receiving high doses of corticosteroids

*Note:  It should be noted that while the Beuchel-Pappas total hip resurfacing system was FDA approved in the 1990’s it has largely fallen out of favor in our Plan area due to the degree of wear debris created from the metal femoral head contact with the polyethylene acetabular cup resulting in tissue reaction, component loosening, and a high reoperation rate.

Note:   This policy only addresses total hip resurfacing and does not address partial hip resurfacing of the femoral component only which may be considered medically necessary. A variety of devices have been FDA approved for partial hip resurfacing including the Conserve® and Cormet 2000 femoral resurfacing devices.

Policy/Criteria

1. Metal-on-metal total hip resurfacing with a fully FDA approved total hip resurfacing device (e.g., the Birmingham Hip Resurfacing System and Cormet device), may be considered medically necessary when both of the following criteria are met:
1. Patient is likely to outlive a traditional prosthesis
2. Patient would otherwise require a total hip replacement
2. All other types and applications of total hip resurfacing are considered investigational.

Scientific Background

Initially, there was very minimal published medical literature regarding total hip resurfacing (HR), using either polyethylene components or metal on metal designs.  Some of the early reports used two different types of prostheses, the Wagner and McKinn. The acetabular components of the McKinn prosthesis showed progressive loosening. Based on these results, the investigators developed new design and implantation techniques leading to the Conserve®Plus device.

During subsequent policy updates, review of the peer-reviewed literature identified additional articles.  Amstutz and colleagues reported on 355 patients who received 400 metal-on-metal HR using the Conserve Plus device with a follow-up of two to six years. (2) Of the 355 patients, 54% had University of California Los Angeles activity scores greater than 7; and at four years, 94.4% of components survived per Kaplan-Meier survivorship curves. Revision of the HR to total hip arthroplasty (THA) occurred in only 12 (3%) hips. Beaule and colleagues reported on metal-on-metal HR in 56 patients with Ficat stage III and IV osteonecrosis. (3) Only two hips required THA during follow-up of an average of 4.9 years. While these study results are promising, the authors noted need for further evaluation to determine appropriate patient selection criteria and the most beneficial techniques for femoral bone preparation and fixation.

Some outcomes have been reported with the Birmingham hip resurfacing device suggesting medium to long-term durability. Treacy and colleagues reported the five-year survival of Birmingham hip resurfacing arthroplasty in 144 patients was 98% overall. (4) Failure of the femoral component occurred in three cases within the first two years of the study (two infections and one fracture) in the Treacy study.  Shimmin and Back reviewed 3,497 Birmingham hip resurfacings performed by 89surgeons between April 1999 and April 2004.(5) The authors reported the incidence of femoral neck fracture was 1.46% (50 of 3,497) and the mean time to fracture was 15.4 weeks.  Glyn-Jones and colleagues evaluated the stability of Birmingham hip resurfacing arthroplasties by radiographic analysis in 22 hips in 20 patients. (6) At 24 months, migration of the head of the femoral component was not statistically significant (0.2 mm total three-dimensional).

In support of the application for FDA premarket approval, clinical data on 2,385 Birmingham hip resurfacings performed by a single surgeon in the United Kingdom was presented to the FDA Orthopaedic and Rehabilitation Devices Panel (Panel) in September 2005. Of the 2,385 cases, 27 revisions were required including ten revisions due to femoral neck fracture, six for femoral head collapse, one for dislocation, two for avascular necrosis, and eight for infections.

In February 2007, a TEC Assessment reviewed evidence published through January 2007 on metal on metal total hip resurfacing. (7) The Assessment evaluated studies of individuals with advanced degenerative joint disease of the hip who received a HR device and that reported data on short- and long-term clinical outcomes, including benefits and harms, as an alternative to total hip arthroplasty (THA). TEC identified one randomized controlled trial, (8) and 12 uncontrolled series. (9-17) For the assessment, these published trials, the FDA PMA submission data (18), and information from the Australian Orthopedic Association (AOA) National Joint Replacement Registry (19) were evaluated.

In the randomized controlled trial (100 patients in each group), the HR device was implanted in patients who were younger (49 to 51 years old) and had a smaller body mass index (17 to 49 kg/m 2 ) than those who usually undergo THA ( >= 65 years old), and the majority comprised male patients (63% to 68%) who were being treated for advanced osteoarthritis (75%). (8) In comparison to THA, the perioperative differences demonstrate that HR reduced the surgical time (p<0.001), decreased the hospital stay (5 vs. 6.1 days), and used a longer incision (p<0.001). Both groups had a similar incidence of complications; with two deep vein thromboses per group, and two THA patients had deep infections without recurrence. At 12 months’ follow-up, two patients in the THA group required revision for femoral head aseptic loosening at six and nine months, respectively, and none experienced femoral head fracture. Both groups showed substantial improvement over preoperative status on functional outcomes measures and reported satisfaction or very high satisfaction scores (98%).

The 12 published series reporting clinical outcomes after HR included a total of 2,076 patients (71% male) who ranged in mean age from 34 to 57 years. Although most patients had advanced osteoarthritis (80%), some studies enrolled patients with femoral head osteonecrosis (11, 14) and/or developmental hip dysplasia (4), and only three used the FDA-approved Birmingham device. (3,9,10) Mean follow-up was approximately three years, but ranged from less than one year (15) to 12 years, (14) and the proportion of enrolled patients available at follow-up was generally 90% to 100%, (9,13,14) but as low as 22%. (17) Of the 2,076 patients treated with HR, 57 (2.7%) required revision to THA, most for femoral neck fracture or component loosening; the proportion of cases that required revision ranged from 0.3% (13) to 22% (15).

Although the 12 published series exhibit little consistency in outcomes measures used, the aggregate data suggest that HR-treated patients who do not require a revision have substantial symptomatic improvement of pain and hip function over presurgical status. Moreover, HR patients report substantial activity levels and returning to playing sports after treatment. (4,13)

The TEC Assessment also evaluated the patient safety and effectiveness data considered for the FDA submission of the Birmingham device from the McMinn Cohort (18), which are supported by unpublished data on 3,374 hips implanted by 140 surgeons and published reports on more than 3,800 hips treated by multiple surgeons (Worldwide Cohort).

The McMinn Cohort included 71% men and 29% women, ranging in age from 13 to 86 years (average, 53 years). The predominant diagnoses for treatment were advanced osteoarthritis (75%), dysplasia (16%), avascular necrosis (4%), inflammatory arthritis (2%), and “other” (3%). The Worldwide Cohort was reportedly comparable. At the five-year follow-up, a total of 76 revisions to THA were reported (2.26%), resulting from events similar to those reported for the McMinn Cohort. (18) In addition, results of the Oswestry-Modified Hip Scores for both cohorts showed improvement at five years from a baseline mean of 60.1 to 94.8 (58%). With regard to long-term safety, literature summaries provided to the FDA demonstrated increased serum and urinary concentrations of metal ions postoperatively in patients with THA, particularly after metal-on-metal procedures, but data show no conclusive evidence of significant detrimental effects. (18)

The AOA registry’s annual report for 2006 is based on 92,210 primary THAs, including 84,872 primary THAs, 7,205 metal-on-metal HRs, and 133 thrust-plate procedures. (19) Some of these data may include patients reported in the Worldwide Cohort. In general, resurfacing procedures were used more often in men than women (73% vs. 56%) and in younger patients (90% <65 years) than primary THA. At five years’ follow-up, conventional THAs showed fewer revisions (1.7%) than HRs (2.2%), but THA prostheses may not be reflected, and no patient demographic characteristics were available for comparison.

TEC concluded that use of the FDA-approved metal-on-metal HR devices meets the TEC criteria as an alternative to THA in patients who are candidates for THA and who are likely to outlive a traditional prosthesis. A substantial body of evidence shows that total hip resurfacing is associated with consistent and strong symptomatic and functional improvements comparable to those obtained with current total hip arthroplasty in patients less than 65 years old. Total hip resurfacing differs procedurally from arthroplasty in conserving a patient’s native femoral bone stock; this difference is important should subsequent revision surgery be required. The available evidence shows that HR’s short-term symptomatic and functional health benefits are at least as good as those of THA over midterm follow-up, with no substantial differences in revision rates, among patients younger than 65 years who are likely to outlive a traditional prosthesis. Also, inference from the available long-term evidence suggests that HR will be at least as beneficial as THA in patients who are likely to outlive a traditional prosthesis, based on 1) appropriate patient selection, 2) the fact that HR is a bone-conserving procedure that preserves the femoral head and stock largely intact, and 3) substantial 5-year follow-up of device survival.

There is minimal published medical literature regarding total hip resurfacing using polyethylene components.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual; Policy No. 7.01.80
2. Amstutz HC, Beaulé PE, Dorey FJ, et al. Metal-on-metal hybrid surface arthroplasty: two to six-year follow-up study. J Bone Joint Surg Jan 2004;86A(1):28-39
3. BeaulePE, Amstutz HC, Le Duff M et al. Surface arthroplasty for osteonecrosis of the hip: hemiresurfacing versus metal-on-metal hybrid resurfacing. J Arthroplasty 2004;19(8 suppl 3):54-8
4. Treacy RB, McBryde CW, Pynsent PB. Birmingham hip resurfacing arthroplasty. A minimum follow-up of five years. J Bone Joint Surg Br 2005;87(2):167-70
5. Shimmin AJ, Back D. Femoral neck fractures following Birmingham hip resurfacing: a national review of 50 cases. J Bone Joint Surg Br 2005;87(4):463-4
6. Glyn-Jones S, Gill HS, McLardy-Smith P et al. Roentgen stereophotogrammetric analysis of the Birmingham hip resurfacing arthroplasty. A two-year study. J Bone Joint Surg Br 2004;86(2):172-6
7. 2007 TEC Assessments. Metal-on-Metal Total Hip Resurfacing. BlueCross and BlueShield Technology Evaluation Center  www.bcbs.com/betterknowledge/tec/vols/22/metal-on-metal-total-hip.html  (Verified 7/10/07)
8. Vendittoli PA, Lavigne M, Roy AG et al. A prospective randomized clinical trial comparing metal-on-metal total hip arthroplasty and metal-on-metal total hip resurfacing in patients less than 65 years old. HIP Int 2006;16(suppl 4):S73-S81
9. Back DL, Dalziel R, Young D et al. Early results of primary Birmingham hip resurfacings. J. Bone Joint Surg, Series B 2005;87(3):324-9
10. De Smet KA. Belgium experience with metal-on-metal surface arthroplasty. Orth Clin North Am 2005;36:203-213
11. Mont MA, Seyler TM, Marker DR et al. Use of metal-on-metal total hip resurfacing for the treatment of osteonecrosis of the femoral head. J Bone Joint Surg Am 2006;88(suppl 3):90-7
12. Schmalzried TP, Silva M, de la Rosa MA et al. Optimizing patient selection and outcomes with total hip resurfacing. Clin Orthop Relat Res 2005;441:200-4
13. Daniel J, Pynsent PB, McMinn DJ. Metal-on-metal resurfacing of the hip in patients under the age of 55 years with osteoarthritis. J Bone Joint Surg Br 2004;86(2):177-84
14. Revell MP, McBryde CW, Bhatnagar S et al. Metal-on-metal hip resurfacing in osteonecrosis of the femoral head. J Bone Joint Surg Am 2006;88(suppl 3):98-103
15. Cutts S, Datta A, Ayoub K et al. Early failure modalities in hip resurfacing. HIP Int 2005;15(3):155-158
16. Lillikakis AK, Vowler SL, Villar RN. Hydroxylapatite-coated femoral implant in metal-on-metal resurfacing hip arthroplasty: minimum of two years follow-up. Orth Clin North Am 2005;36:215-222
17. Siebel T, Maubach S, Morlock MM. Lessons learned from early clinical experience and results of 300 ASR hip resurfacing implantations. Proc Inst Mech Eng [H] 2006;220(2):345-53
18. U.S.Food and Drug Administration Center for Devices and Radiological Health. Summary of safety and effectiveness data: Birmingham Hip Resurfacing (BHR) System. May 9, 2006. Available online at www.fda.gov/cdrh/pdf4/p040033b.pdf  (Verified 7/10/07)'
19. Australian Orthopedic Association. National Joint Replacement Registry Annual Report, 2006. Available online at www.aoa.org.au/docs/njrrrep06.pdf  (Verified 7/10/07)

Cross References

Minimally Invasive Total Hip Arthroplasty, Regence Medical Policy Manual, Surgery, Policy No. 125

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