Total Hip Resurfacing
DESCRIPTION
Total hip resurfacing may be considered an alternative to total hip replacement. It has been looked at for a broad range of individuals with osteoarthritis, rheumatoid arthritis and avascular necrosis. Total hip resurfacing may be viewed as a time-buying procedure to delay the need for a total hip arthroplasty in young active individuals who would potentially outlive a total hip prosthesis.
Total hip resurfacing has undergone various evolutions over the past several decades. Modifications in prosthetic design, composition (metal or ceramic-on-polyethylene to metal-on-metal) and implantation techniques have occurred. Total hip resurfacing consists of a femoral shell and an acetabular cup. The femoral shell is implanted over the resurfaced femoral head. This femoral shell fits into a metal acetabular cup that is pressed into position in the acetabulum of the pelvis. The femoral neck and femoral canal are preserved.
An example of an FDA approved device used for this procedure is the Birmingham Hip Resurfacing (BHR) system.
POLICY
Metal on metal total hip resurfacing used as an alternative to total hip replacement is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
All other types and applications of total hip resurfacing are considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
Policies with similar titles: Shoulder Resurfacing
MEDICAL APPROPRIATENESS
Total hip resurfacing used as an alternative to total hip replacement is considered medically appropriate if ALL of the following criteria are met:
The individual is a candidate for a total hip replacement with 1 or more of the following criteria:
Advanced joint disease and ALL of the following:
Radiographic evidence (eg, hip joint destruction, severe narrowing, bone deformities, osteonecrosis)
Failure of optimal medical management
Replacement needed because of 1 or more of the following:
Disabling pain
Functional disability
Failure of or not a candidate for more conservative measures
Primary and secondary tumors involving the proximal femur and possibly the acetabulum
Osteonecrosis of femoral head or arthritis secondary to traumatic dislocation or fracture-dislocation
Arthritis secondary to acetabular fracture
Displaced fracture of the femoral neck in elderly patients without dementia
Failed previous hip fixation or reconstruction
Revision of hip arthrodesis
Revision of previous arthroplasty for 1 or more of the following:
Instability of one or both components
Fracture or mechanical failure of the implant
Recurrent or irreducible dislocation
Infection
Treatment of a displaced periprosthetic fracture
The individual is likely to outlive a traditional prosthesis
ADDITIONAL INFORMATION
In the pre-market approval 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
Osteonecrosis 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
In February 2007, a TEC Assessment reviewed evidence published through January 2007 on metal-on-metal total hip resurfacing. The Assessment evaluated studies of individuals with advanced degenerative joint disease of the hip who received a hip resurfacing (HR) device and that reported data on short- and long-term clinical outcomes, including benefits and harms, as an alternative to total hip replacement (THA). TEC identified 1 randomized controlled trial, and 12 uncontrolled series. For the assessment, these published trials, the FDA PMA submission data, and information from the Australian Orthopedic Association (AOA) National Joint Replacement Registry 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%). 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 2 deep vein thromboses per group, and 2 THA patients had deep infections without recurrence. At 12 months’ follow-up, 2 patients in the THA group required revision for femoral head aseptic loosening at 6 and 9 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 and/or developmental hip dysplasia, and only 3 used the FDA-approved Birmingham device. Mean follow-up was approximately 3 years, but ranged from less than 1 year to 12 years, and the proportion of enrolled patients available at follow-up was generally 90% to 100%, (8, 12, 13) but as low as 22%. 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% to 22% (14).
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.
The TEC Assessment also evaluated the patient safety and effectiveness data considered for the FDA submission of the Birmingham device from the McMinn Cohort, 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 reportably comparable. At the 5-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. In addition, results of the Oswestry-Modified Hip Scores for both cohorts showed improvement at 5 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. (17)
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. 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 5 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.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2008). Total hip resurfacing (7.01.80). Retrieved June 5, 2009 from BlueWeb.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2007, August). Metal on metal total hip resurfacing for degenerative hip disease. Retrieved June 5, 2009 from ECRI Institute. (26 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2006, July). Total Hip Resurfacing. Retrieved June 19, 2007 from www.Hayesinc.com/subscribers.
The Technology Evaluation Center. (2007, May). Metal-on-metal hip resurfacing. (Vol. 22, No. 3). Retrieved July 11, 2007 from http://www.bcbs.com/blueresources/tec/vols/22/22_03.pdf.
U. S. Food and Drug Administration. (2006, May). Center for Devices and Radiological Health. Approval letter: Birmingham hip resurfacing (BHR) system. Retrieved June 15, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040033a.pdf.
ORIGINAL EFFECTIVE DATE: 11/11/2006
MOST RECENT REVIEW DATE: 6/23/2010
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