Coverage Policy Manual
Policy #: 2006037
Category: Surgery
Initiated: August 2017
Last Review: September 2018
  Hip Resurfacing

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 (THR), consisting of an acetabular cup and femoral shell. 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 (THA), particularly in young active patients who would potentially outlive a total hip prosthesis. Therefore, hip resurfacing could be viewed as a time-buying procedure to delay the need for a THA. Proposed advantages of THR compared to THA include preservation of the femoral neck and femoral canal, thus facilitating revision or conversion to a THR, 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 THA.
 
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 THR have been composed of polyethylene. However, over the years it became apparent that device failure was frequently related to the inflammatory osteolytic reaction to polyethylene debris wear particles. Metal acetabular components have since been designed to improve implant longevity. Sensitivity to wear particles from metal-on-metal (MoM) chromium and cobalt implant components are of increasing concern.
 
Regulatory Status
In May 2006, the FDA granted premarket application (PMA) approval to the Birmingham Hip Resurfacing (BHR) system for use in patients requiring primary hip resurfacing 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 8 sites where clinical and radiographic data will be assessed annually through 5 years and at 10 years. Also, determine cobalt and chromium serum concentration and renal function in these patients at 1, 4, and 10 years.
    • Implement a training program to provide clinical updates to investigators.
 
The Cormet Hip Resurfacing System (Corin) and the Conserve®Plus (Wright Medical Technology) are metal-on-metal total hip resurfacing systems that were FDA approved in 2007 and 2009, respectively. The approval order for the Cormet system states that the device is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; 2) inflammatory arthritis such as rheumatoid arthritis. The Cormet Hip Resurfacing System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
 
A variety of devices have been cleared by the FDA for partial hip (femoral) resurfacing under the FDA’s 510(k) mechanism. Some surgeons may be using a femoral resurfacing component together with an acetabular cup (total arthroplasty component) as an "off-label" application.
 
In January 2013, the U.S. Food and Drug Administration (FDA) issued a safety communication on metal-on-metal hip implants (including both hip resurfacing and hip replacement) (FDA, 2013). The FDA states that metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.
    • With metal-on-metal implants, some tiny metal particles wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.
    • Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).
 
Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.
 
Coding
There is no specific CPT code for total hip resurfacing. The American Academy of Orthopaedic Surgeons’ coding committee has written several articles stating that this procedure should be reported with the regular total hip CPT code 27130 (arthroplasty, acetabular and proximal femoral prosthetic replacement [total hip replacement], with or without autograft or allograft). It might also be reported with code 27299 (unlisted procedure, pelvis or hip joint).
 
Effective 10/1/08, there is a specific HCPCS “S” code for this procedure:
 
S2118: Metal-on-metal total hip resurfacing, including acetabular and femoral components
 
 
 

Policy/
Coverage:
Effective, December 2009
Total hip resurfacing, using an FDA approved system being used for its approved labeled indications, meets primary coverage criteria for effectiveness and is covered as an alternative to total hip replacement in patients who are candidates for total hip replacement, who are likely to outlive a traditional prosthesis and do not have any of the following contraindications for total hip resurfacing:
    • 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
    • Females of child bearing age due to unknown effects on the fetus of metal ion release
     
Partial hip resurfacing with an FDA-approved device may be considered medically necessary in patients with osteonecrosis of the femoral head who have one or more contraindications for metal-on-metal implants and meet the following criteria:
    • The patient is a candidate for total hip replacement; AND
    • Is likely to outlive a traditional prosthesis; AND
    • The patient has known or suspected metal sensitivity or concern about potential effects of metal ions; AND
    • There is no more than 50% involvement of the femoral head; AND
    • There is minimal change in acetabular cartilage or articular cartilage space identified on radiography.
 
The use of a hip resurfacing system that does not have PMA or 510(k) FDA approval is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, any use of a resurfacing system without a FDA PMA or 510(k) approval is considered investigational and is not covered.  
 
Effective, February 2008 to November 2009
Total hip resurfacing, using an FDA approved system being used for its approved labeled indications, meets primary coverage criteria for effectiveness and is covered as an alternative to total hip replacement in patients who are candidates for total hip replacement and who are likely to outlive a traditional prosthesis.  
 
The use of a hip resurfacing system that does not have PMA or 510(k) FDA approval is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, total hip resurfacing, using an FDA approved resurfacing system being used for its approved labeled indications, is covered as an alternative to total hip replacement in patients who are candidates for total hip replacement and who are likely to outlive a traditional prosthesis.  Any use of a resurfacing system without a FDA PMA or 510(k) approval is considered investigational and is not covered.  Investigational services are  exclusions in the member benefit contract.
 
Effective, November 2006 to January 2008
Total hip resurfacing does not meet primary coverage criteria for effectiveness and is not covered.
 
For contracts without primary coverage criteria total hip resurfacing is considered investigational and is not covered.  Investigational services are exclusions in the member benefit contract.

Rationale:
In 1996, Schmalzried and colleagues reported on the initial experience of metal-on-metal total hip resurfacing in 21 hips and 19 patients. Two different types of prostheses (4 Wagner and 17 McKinn) were used. 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. This same group of investigators is now involved in the clinical trial of the Conserve®Plus device.
 
Review of the peer-reviewed literature identified additional articles. Amstutz and colleagues reported on 355 patients who received 400 metal-on-metal surface arthroplasties using the Conserve Plus device with a follow-up of 2–6 years.  Of the 355 patients, 54% had University of California Los Angeles activity scores greater than 7; and at 4 years, 94.4% of components survived per Kaplan-Meier survivorship curves. Revision of the surface arthroplasty to total hip replacement occurred in only 12 (3%) hips. Beaule and colleagues reported on metal-on-metal surface arthroplasty in 56 patients with Ficat stage III and IV osteonecrosis.  Only 2 hips required total hip replacement 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 5-year survival of Birmingham hip resurfacing arthroplasty in 144 patients was 98% overall.  Failure of the femoral component occurred in 3 cases within the first 2 years of the study (2 infections and 1 fracture) in the Treacy study. Shimmin and Back reviewed 3,497 Birmingham hip resurfacings performed by 89 surgeons between April 1999 and April 2004.  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.  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 10 revisions due to femoral neck fracture, 6 for femoral head collapse, 1 for dislocation, 2 for avascular necrosis, and 8 for infections.
 
Though the Birmingham hip resurfacing device has been granted a PMA by the FDA, there still are ongoing questions about the intermediate and long-term durability of this device compared with standard hip arthroplasty. There also are continued questions about short-term revisions (due to femoral neck fracture) and also potential concerns about shedding of metal particles.
 
2007 Update
In February 2007, a Blue Cross Blue Shield Association Technology Evaluation Center (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). The TEC identified one 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/m2) 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%, 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%.
 
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 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.
 
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.
 
The TEC concluded that use of the FDA-approved metal-on-metal HR devices meets the Blue Cross Blue Shield Association Technology Evaluation Center criteria as an alternative to THA in patients who are candidates for THA and who are likely to outlive a traditional prosthesis. The available evidence shows that HR 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.
 
2008 Update
Mont et al (2006) described the results of the FDA-approved Investigational Device Exemption (IDE) prospective, multicenter trial of the Conserve Plus hip resurfacing system. The investigators identified a number of risk factors for complications after the first 292 procedures; these included the presence of cysts, poor bone quality, leaving reamed bone uncovered, minimizing the size of the femoral component to conserve acetabular bone, and malpositioning of the acetabular shell. Modification of inclusion criteria and surgical technique in the next 906 patients (1,016 hips) resulted in a decreased rate of femoral neck fracture (from 7% to <1%). There was also a trend toward reduction in other types of complications (e.g., nerve palsy was reduced from 4.1% to 2.2% and loosening of the acetabular cup from 3.4% to 1.9%). No differences between the two cohorts were observed in the Harris hip score (93 vs. 93) or the SF-12
 
2009 Update
An updated search of the MEDLINE database for the period of May 2008 through October 2009 identified 2 qualitative systematic reviews, 2 randomized controlled trials comparing THR with large-diameter head THA and other publications concerning factors in survival such as patient selection criteria and the surgeon’s learning curve.
 
One of the systematic reviews compared outcomes from THR and THA in studies with short- to mid-term follow-up (Marker, 2009). The 7 comparative studies that assessed return to sports and activity showed either similar outcomes for the two procedures or advantages for the THR group. Three additional studies assessed gait, and 1 study was identified that assessed postural balance; all 4 showed similar or better outcomes for THR than THA. Two studies were discussed that compared the outcomes of conversion of failed THR to THA with primary THA. One of the 2 studies was reviewed above (Ball, 2007). The second was a 2009 report that compared outcomes of 39 patients whose resurfacing was converted to THA with a group of primary THA patients that had been matched by gender, age, body mass index (BMI), and preoperative Harris hip score; all procedures had been performed by the same surgeon (McGrath, 2009) Perioperative measures were similar except for the mean operating time, which was 19 minutes longer for the revision group. At an average 45 months follow-up, the mean Harris hip scores were similar for the 2 groups (score of 92 for conversion to THA and 94 for primary THA).
 
In 2008, Queseda, Marker and Mont published a qualitative systematic review that focused on advantages and disadvantages of THR in comparison with THA (Quesada, 2008).  Advantages were reported to include possible bone conservation on the femoral side, lower dislocation rates, more range-of-motion, more normal gait pattern, increased activity levels, increased ease of insertion with proximal femoral deformities or retained hardware, and straightforward revision. Possible disadvantages of resurfacing were reported to be increased difficulty to perform the procedure, increased acetabular bone stock loss, femoral neck fractures, and the effects of metal ions. Although prospective controlled studies with long-term follow-up are needed for conclusive evaluation of these issues, the literature reviewed by these investigators suggests an increased risk of femoral neck fractures in post-menopausal women and smallboned men. Queseda et al. conclude that THR is most appropriate in young (less than 60 years) active men.
 
For a 2009 report on patient selection criteria for THR, Nunley and colleagues reviewed 207 publications, the majority of which they found to have little or no description of the patient population, small sample sizes, poor study design, limited control of bias, and inadequate statistical analysis (Nunley, 2009). The literature showed no clear consensus on the upper age limit for male patients, but the most commonly used criteria was age younger than 65 years. Nine articles suggested that female patients should be cautiously evaluated before performing hip resurfacing, especially if they are postmenopausal or have decreased bone mineral density. Some of the data reviewed was from the Australian joint replacement registry, where women 65 or older were observed to have a revision rate of 11% at 4 years. This was compared with men younger than 55 years of age who had a revision rate of less than 2%. Both of these cohorts (older women and younger men) have revision rates of 2% after THA. The evidence reviewed by Nunley et al. also indicates that obesity, defined as BMI > 35 kg/m2 can be viewed as a relative contraindication to THR, but not THA. Femoral head cysts, head-neck junction abnormalities, and poor bone density may also be considered risk factors for implant failure. The literature on metal sensitivity and the presence of aseptic lymphocytic vasculitis-associated lesions (ALVAL) is evolving, and the potential for transplacental transfer of metal ions is a concern for young female patients who have the potential to become pregnant in the future. The authors concluded that the best candidates for hip resurfacing are men under age 65 with osteoarthritis and relatively normal bony morphology.
 
Two randomized controlled trials were published in 2009 that randomized patients to THR or THA with a large diameter metal-on-metal implant (Lavigne, 2009) (Garbuz, 2009). The study by Lavigne et al. tested the hypothesis that the observed improvement in activity with THR is due either to patient selection bias or to the larger femoral head with THR.  In order to test this hypothesis, 48 patients were randomized to either THR or largehead THA. The patients and the evaluators at the gait laboratory were kept blinded to the type of arthroplasty until 1 year after surgery. There were no differences between the two groups for the majority of measures at 3, 6, and 12 months after surgery. Specifically, similar results were observed for normal and fast walking, postural evaluations, timed up and go test, hop test, hip flexor and abductor strength ratio. The THR group performed better during the functional reach test, and the THA group completed the step test 3 seconds faster than the THR group. The WOMAC, SF-36, Merle d’Aubigne, and UCLA activity scores were similar in the 2 groups. Garbuz and colleagues randomized 107 patients to THR or large-head metal-on-metal THA.  There was no difference in WOMAC or SF-36 scores for the 73 patients who had been followed for at least 1 year. However, for the subset of patients who had been tested for serum levels of cobalt and chromium, cobalt was 10-fold higher and chromium was 2.6 fold higher in the large head metal-on-metal THA group than the THR group. This was a 46-fold increase from baseline in serum cobalt and a 10-fold increase from baseline in serum chromium for the largediameter head THA group, possibly related to particulate wear at the head-neck junction. Both of these studies support the hypothesis that the improved activity observed in THR patients is due to the larger diameter components used in resurfacing.
 
The increase in serum cobalt and chromium ions with metal-on-metal THR remains a concern. One retrospective study of 610 consecutive hip resurfacings (120 with more than 5-year follow-up) reported that failure was possibly related to metal debris on 0.5% of THRs (Steffen, 2008).  However, after examining histological samples taken at the time of revision, Olivere and colleagues concluded that the rate of metallosis-related revision in their series of 463 consecutive patients was 3% at 5 years(Ollivere, 2009).  All of the patients in this series had been recruited into the local arthroplasty follow-up program at the time of the primary surgery; 437 (94%) returned for clinical and radiological follow-up with a mean follow-up of 43 months (range, 6-90 months). Case notes, radiographs, and magnetic resonance scans were available for the 13 revisions (2.8%, 12 patients). Histological findings were available for 12 cases, and were rereviewed by a histopathologist with experience in metal wear and debris. In 7 cases, the histological findings were consistent with a response to metal wear debris. Survivorship analysis gave an overall survival rate of 95.8% at 5 years, with an end-point survival of 96.9% at 5 years for metallosis requiring revision. The relative risk for female gender in the metallosis group was 4.94. Also associated with metallosis were a smaller femoral component, greater abduction angle, and a higher BMI.
 
Other studies suggest a high learning curve for THR related to the increased difficulty in accessing the acetabular compartment. For example, in one study most of the failures were related to early acetabular loosening (Kim, 2008).  A report by Nunley et al. suggests that for experienced hip surgeons the learning curve for avoiding early complications (e.g., early femoral fracture) is 25 cases or less, but the learning curve for achieving the desired component positioning is 75-100 cases or more (Nunley, 2009).  Steeply inclined component positioning along with a small size of component have been shown to be associated with metal ion levels, possibly due to an increase in edge loading (De Haan, 2008).
 
Partial Hip Resurfacing for Osteonecrosis
A search of the literature on resurfacing for osteonecrosis identified a number of articles, including a 2005 review and a 2009 study on the topic (Grecula, 2005) (Stulber, 2009).   Both articles discussed comparisons of hemi-resurfacing to THR, referencing a single comparative study by Beaule from 2004; thus, it is unlikely that additional comparative resurfacing studies have been published since 2004 (Beaulé). This literature shows total resurfacing/replacement to provide more consistent and better initial pain relief than partial resurfacing. The increase in poor outcomes with resurfacing is believed to be related to continued abrasion and possible misfit of the femoral component against the native acetabular cartilage. Therefore, for osteonecrosis in younger patients who do not have contraindications for the metal-on-metal prosthesis, total hip resurfacing (femoral and acetabular implant) would be preferred over a femoral component alone.
 
Summary
The evidence available at this time supports the conclusions reached above that hip resurfacing (partial or total) presents an effective alternative for active patients who are considered too young for THA, when performed by surgeons experienced in the technique. The literature on risk factors for metallosis and implant failure is evolving as longer follow-up becomes available. Emerging evidence indicates an increased risk of failure in women due to decreased bone strength and increased risk of metal sensitivity.
 
Therefore, these risk factors should be considered in the overall patient evaluation for total hip replacement.
 
2012 Update
A literature search was conducted through August 2012.  There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key literature identified in the search:
 
Patient Selection Criteria
 
In 2011, the American Academy of Orthopaedic Surgeons (AAOS) provided a technology overview of modern MoM hip implants (AAOS, 2011). The U.K./Wales registry reported that hip resurfacing patients in all age groups, except males younger than 55 years of age, were at an increased revision risk compared to cemented total hip arthroplasty with an unspecified bearing surface. The Australian registry reported hip resurfacing patients 65 years of age or older to have the highest revision risk. Head size and risk of revision for THR were inversely related to each other. Patients receiving the smallest femoral head components (e.g., women) had the greatest risk of revision. The implant size was associated with poorer outcomes when gender/implant size interaction was analyzed. This analysis supports the view that THR is most effective in men who are too young to receive THA.
 
Efficacy of Total Hip Resurfacing vs Total Hip Arthroplasty
 
In 2011, Jiang et al. published a meta-analysis comparing MoM THR with THA in patients younger than 65 years (Jiang, 2011). Included were 4 randomized controlled trials with a total of 968 patients. Hip function scores were similar between the 2 groups, although the resurfacing group showed higher activity levels. The meta-analysis by Jiang et al. compared revision rates for MoM THR versus THA from 4 randomized or controlled trials with 968 patients younger than 65 years (Jiang, 2011). Analysis found increased rates of revision with THR at 1–10 year follow-up; the relative risk was 2.60. However, this analysis did not evaluate the effect of age, bearing head size, or gender, which have been shown to have a significant effect on revision rates in registry data (AAOS, 2011). As discussed above, the U.K./Wales registry reported that hip resurfacing patients in all age groups, except males younger than 55 years of age, were at an increased revision risk compared to cemented total hip arthroplasty with an unspecified bearing surface. Analysis of data from the Australian registry found that head size and risk of revision for THR were inversely related to each other. Patients receiving the smallest femoral head components (e.g., women) had the greatest risk of revision. The implant size was associated with poorer outcomes when gender/implant size interaction was analyzed.
 
Amstutz et al. reported 12-year follow-up (range, 10.8 to 12.9 years) from the first 100 hip resurfacings at their institution in 2010 (Amstutz, 2010). The 89 patients in this series were followed annually with radiographs, range of motion, and questionnaires. Two patients were lost to follow-up, and 5 patients died during the follow-up period of causes unrelated to the surgery. Eleven hips had conversion to THA. Kaplan-Meier survivorship of the resurfacing implant was 93.9% at 5 years and 88.5% at 10 years. Subgrouping by femoral component size showed 10-year survival of 95.6% for a component size of greater than 46 mm, 83.8% for component sizes of 44 or 46 mm, and 78.9% for a component size equal to or less than 42 mm. Multivariate analysis showed that low BMI, small femoral component size, and large defects in the femoral head were risk factors for failure. High scores for activity level were not associated with an increased risk of revision.
 
Gross et al. reported mean 8-year follow-up (range, 6-11 years) of 373 hips in 329 consecutive patients from the first multicenter FDA-regulated trial on hip resurfacing with the Cormet prosthesis (Gross, 2012).  All patients were requested to come back for follow-up at 6 weeks, 1 year, 2 years, and every other year. A variety of methods were used to complete follow-up for patients who could not return to the study site, including phone interviews, mail-in questionnaires, radiographs, and physical examination by a local physical therapist. Twenty-one (6%) required revision, 5 for femoral neck fractures, 12 for component loosening, 2 for late deep infections, and 2 for an adverse wear reaction (0.5% at 7 years). Four additional hips showed radiographic signs of loosening but did not undergo revision. Kaplan-Meier survivorship at 11 years was 93% for revision for any reason and 91% including radiographic loosening. The learning curve was at least 200 cases, with survival of 93% for the first 100 cases, 93% for the second 100 cases, and 98% for the last 73 cases.
 
Other studies also suggest a high learning curve for THR related to the increased difficulty in accessing the acetabular compartment. For example, in one study most of the failures were related to early acetabular loosening (Kim, 2008). A report by Nunley et al. suggests that for experienced hip surgeons the learning curve for avoiding early complications (e.g., early femoral fracture) is 25 cases or less, but the learning curve for achieving the desired component positioning is 75–100 cases or more (Nunley, 2010).
 
It is thought that revision of THR to THA might have better outcomes than THA-THA revision, but little data are available to support this assumption. In 2010, de Steiger et al. reported outcomes of revised THR from the Australian Joint Replacement Registry (de Steiger, 2010). A total of 437 revisions were reported (out of 12,093 primary THR, approximately 4%) between 1999 and 2008. After excluding 39 cases of revision for infection, the major reason for revision of primary THR was fracture of the femoral neck (43%), followed by loosening/lysis (32%), metal sensitivity (7%), and pain (6%). A femoral-only revision, which converts the joint to a conventional total hip replacement, was performed in 247 of the 397 revisions (62%) undertaken for reasons other than infection. At 3 years, the rate of re-revised THR-THA was 7%, compared with 2.8% of primary conventional THA. Reasons for re-revision included loosening/lysis (n=6), infection (n=4), dislocation of prosthesis (n=1), and fracture (n=2). At 5 years, femoral-only re-revision (7%) was similar to re-revision of both the acetabular and femoral components (5%), but the rate of acetabular-only re-revision was 20%. A more relevant outcome for this policy, one that the investigators did not assess, would be a comparison of the re-revision rate of THR-THA versus THA-THA revisions.
 
Adverse Events: The AAOS technology overview found that limited data exist comparing the prevalence of adverse clinical problems with MoM hip implants (both THR and THA) or for implants with other bearing surfaces (AAOS, 2011). Several studies noted a correlation between suboptimal hip implant positioning and higher wear rates, local metal debris release, and consequent local tissue reactions to metal debris (e.g., soft tissue masses or “pseudotumors”). Several studies reported elevated serum metal ion (cobalt and chromium) concentrations in patients with MoM hip articulations, especially in patients with malpositioned implants. However, the technology overview concluded that the clinical significance of elevated serum metal ion concentrations remains unknown. The U.K./Wales registry began gathering data on soft tissue reactions in July of 2009, but had too little data when the most recent report was published.
 
Local tissue reaction to wear particles (cobalt and chromium ions) with MoM components is an area of increasing concern. In 2011, Williams et al. assessed the prevalence of pseudotumor formation by ultrasound in asymptomatic patients with MoM THA (n=31) or MoM THR (n=21) (Williams, 2011).  Results were compared with 24 asymptomatic patients with a metal-on-polyethylene THA. At a minimum of 2 years after surgery (mean not reported), 10 patients (32%) in the metal-on-metal THA group had a solid (n=7) or cystic mass (n=3), 5 patients (25%) in the THR group had a solid (n=3) or cystic mass (n=2), and one patient (4%) in the metal-on-polyethylene THA group had a cystic mass. Isolated fluid collection was similar in the 3 groups (10%, 5%, and 8%, respectively). Serum chromium and cobalt ion levels in patients with MoM prostheses ranged from 2 to 720 times the upper limit of normal. There was no correlation between the serum metal ion levels and the size of pseudotumor abnormality and no significant difference in serum metal ion levels in patients with pseudotumor formation than in patients without pseudotumors in this small study. The high percentage of patients diagnosed with a pseudotumor in this study is due in part to a definition of pseudotumor that included cystic without solid mass.
 
Kwon et al. determined the prevalence of asymptomatic pseudotumors after MoM THR in 201 hips (Kwon, 2011). All patients who had surgery at least 3 years previously (n=228) were invited to participate in this study. The 158 patients who agreed to participate underwent evaluation by ultrasound, followed by biopsy and magnetic resonance imaging (MRI) if a tumor was identified on ultrasound. The mean follow-up was 61 months (range, 36-88). Pseudotumors that contained both cystic and solid components were identified in 4.4% of patients (6 female, 1 male) and 6.5% of resurfaced hips. Histological examination of the pseudotumors showed extensive necrosis of connective tissue and scattered aggregates of metal particles within necrotic macrophages in extracellular tissue. The pseudotumors were associated with significantly higher cobalt and chromium levels from serum and hip aspirate.
 
Summary
Based on potential ease of revision when compared with THA, the evidence available at this time supports the conclusions that hip resurfacing (partial or total) presents a reasonable alternative for active patients who are considered too young for THA, when performed by surgeons experienced in the technique. The efficacy of THR performed with current techniques is similar to THA over the short to medium term, and THR may allow for easier conversion to a THA for younger patients who are expected to outlive their prosthesis. The literature on risk factors for metallosis, pseudotumor formation, and implant failure is evolving as longer follow-up becomes available. Due to the uncertain risk with metal-on-metal implants, the risk/benefit ratio needs to be carefully considered on an individual basis. In addition, emerging evidence indicates an increased risk of failure in women, possibly due to smaller implant size. Therefore, these risk factors should also be considered in the overall patient evaluation for total hip resurfacing, and patients should make an informed choice in conjunction with their treating physicians.
 
Practice Guidelines and Position Statements
In 2011, the California Technology Assessment Forum (CTAF) concluded that there is no evidence that the potential benefits of hip resurfacing outweigh the potential risks (CTAF, 2011). Revision rates appear to be higher in patients receiving THR procedures than in those receiving THA, which is of particular importance since the THR procedure targets young people. This risk may be particularly high in women. In addition, the elevated levels of metal ions are concerning. Although the clinical significance of these elevated ion levels is still uncertain, they are implicated in the development of aseptic lymphocytic vasculitis-associated lesions (ALVAL), often seen in aseptic failure of THR. Pseudotumors appear to be a more severe manifestation of ALVAL. It is recommended that metal-on-metal hip resurfacing using the BHR, Cormet 2000, or Conserve®Plus devices does not meet CTAF criteria 3-5 for safety, efficacy, and improvement in health outcomes for patients as an alternative to THA.
 
In 2011, the American Academy of Orthopaedic Surgeons (AAOS) provided a technology overview of modern metal-on-metal hip implants (both THA and THR) (AAOS, 2011). This document does not make recommendations for or against the use of metal-on-metal hip implants. Readers are encouraged to consider the information presented in the technology overview and reach their own conclusions.
 
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.
 
In 2012 the United Kingdom’s National Institute for Health and Care Excellence made the following medical device alert concerning metal-on-metal hip resurfacing (NICE, 2012):
    • MoM hip resurfacing is recommended as an option for people with advanced hip disease who would otherwise receive a conventional primary total hip replacement (THR) and are likely to live longer than the device is likely to last. When considering MoM hip resurfacing surgeons should bear in mind:
        • how active the individual is, and
        • that the evidence available at the moment for the clinical effectiveness and cost effectiveness of MoM hip resurfacing comes mainly from studies that have involved people less than 65 years of age.
    • Information on MoM resurfacing operations carried out should be collected as part of a UK national joint registry. The information collected will help the NHS to gather evidence on both the clinical effectiveness and cost effectiveness of MoM hip resurfacing.
    • Until more long-term evidence is available, NICE recommends that surgeons should choose a device for MoM resurfacing for which there is at least 3 years' evidence. This evidence should show that the device is likely to meet a target of less than 1 in 10 devices needing replacing over 10 years.
    • MoM hip resurfacing should be performed only by surgeons who have received training in the technique.
    • Surgeons should make sure that people considering having MoM hip resurfacing understand all the risks and benefits associated with it, and are aware that less is known about the safety and reliability of MoM devices than about conventional cup and ball THR devices.
 
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In a series of 447 patients younger than 50 years of age, implant survival in women was 96.1% at 10 years and 91.2% at 14 years, compared with 100% for men at both 10 and 14 years (Matharu, 2013).  Female gender (p=0.047) and decreasing femoral head size (p=0.044) were significantly associated with an increased risk of revision. Analysis of 162 patients 65 years of age or older found 10-year survival of 98.9% in men and 91.9% in women (Pailhe, 2014). Implant survival was negatively associated with increasing age (p=0.014) and decreasing femoral head size (p=0.024), with a nonsignificant trend for a negative association with female gender (p=0.079).
 
In 2014 the United Kingdom’s National Institute for Health and Care Excellence (NICE) issued an updated technology guidance on THA and THR for end-stage arthritis of the hip (NICE, 2014). NICE concluded that both THA and THR are options for treating end-stage arthritis of the hip, although clinicians may be more likely to offer resurfacing arthroplasty to men than to women because higher revision rates have been observed in women. The appraisal committee concluded that THA was more effective and less costly than THR in all analyses, that revision rate was the most important key driver of costs and quality-adjusted life years, and that because the predicted revision rate of THA was less than 5% at 10 years in the population for whom both THA and THR were suitable, the revision rate standard for THR should be the same as that for THAs. NICE recommends specific prostheses for THA and THR only if the prostheses have revision rates of 5% or less at 10 years.
 
2015 Update
A literature search conducted through August 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Clinical Studies
A RCT reported in 2015 was intended to evaluate clinical and functional outcomes of THR using the Birmingham system and to compare it with that of cementless hip arthroplasty in patients under the age of 55 years (Haddad, 2015).  Between 1999 and 2002, 80 patients were enrolled into the study; however, only 24 consented to random allocation to treatment, 11 to THR and 13 to THA. Eighteen patients refused THR and chose to undergo THA with a 32 mm bearing; 38 patients selected THR. The mean follow-up for all patients was about 12 years (range, 10-14 years). Patients were assessed clinically and radiologically at 1 year, 5 years and 10 years. Outcome measures included Oxford, Harris hip, University of California Los Angeles and University College Hospital functional scores. No differences were observed between the 2 groups in the Oxford or Harris hip scores or in the quality of life scores. At 10 years, more patients who underwent THR were able to run than those who underwent THA (53% vs 19%, respectively; p=0.1), were able to participate in sport activities (86% vs 52%, respectively; p=0.09) and were able to perform heavy manual labor (20% vs 13%, respectively; p=0.19). Patients who had undergone THR exhibited significantly higher functional status scores than those who received a cementless THA at 10 years. Blood levels of cobalt and chromium ions were reported for 72 patients (49 THA, 23 THR); at 5 and 10 years follow-up all remained below a 7 parts per billion (ppb) threshold for toxicity.
 
Cohort Studies
A 2015 study evaluated long-term (minimum, 10-year follow-up) survivorship and functional outcomes of Birmingham THR performed by a single surgeon between 1999 and 2004 in patients with hip OA (Azam, 2015).  In this retrospective cohort study, revision surgery was considered the end point of survivorship. Prosthetic survival analysis was performed with the Kaplan-Meier method. A total 222 patients (244 hips) included 153 men and 69 women. At a mean follow-up of 12 years, 94% of implants were intact. In males implant survival was 95% while in females it was 90%. Failure was seen in 14 patients (16 hips), which included seven female (10%) and seven male (5%) patients. Femoral components failed due to aseptic loosening and varus collapse in eight patients after a mean 9.6 years. Metal allergy was reported in 3 patients (five hips), all of whom were female; 2 of the latter had bilateral resurfacing. Other complications included femoral neck stress fractures in 2 patients and acetabular component loosening in 1 patient. The failure rate was higher in patients who received a THR femoral component size of 46 mm or less (10/16 hips revised).
 
A 2014 prospective cohort study reported long-term implant survival results from a single-surgeon series of Birmingham THR (Daniel, 2014). The earliest 1000 consecutive THR implants comprised 288 women (335 hips) and 598 men (665 hips) of all ages and diagnoses with no exclusions, who were prospectively followed with mailed questionnaires; the first 350 patients (402 hips) also had clinical and radiological review. The mean follow-up was nearly 14 years (range, 12-15 years). In total, 59 patients (68 hips) died 0.7 to 12.6 years following surgery from unrelated causes. Thirty-eight revisions were required at 0.1 to 14 years (median, 9 years) following operation. These included 17 femoral failures (2%) and 7 each due to infections, soft-tissue reactions and other causes. With revision for any reason as the end point, Kaplan-Meier survival analysis showed 97% (95% confidence interval (CI) 97, 98) and 96% (95% CI 95, 96) survival at 10 and 15 years, respectively. Radiologic assessment showed 11 (4%) femoral and 13 (4%) acetabular radiolucencies, and 1 radiological femoral failure (0.3%). Men appeared to have better implant survival (98%; 95% CI, 97 to 99) at 15 years than women (92; 95% CI, 90 to 93); women less than 60 years (90%; 95% CI 88, 93) had the poorest implant survival rate. Patients under 50 years with osteoarthritis had the best results (99% survival at 15 years; 95% CI, 99 to 100), with no failures in men in this group.
 
Adverse Events
A 2014 study was intended to evaluate 10-year survivorship of Birmingham THR; to investigate whole blood (WB) metal ion levels; assess the prevalence of adverse reactions to metal debris (ARM); and, to try to associate blood metal ion levels and symptoms of ARM among patients who underwent THR at a single institution (Reito, 2014).  Between May 2001 and May 2004, 219 patients received 261 THR implants. All patients with intact devices underwent systematic screening comprising clinical examination, WB cobalt and chromium measurements and targeted cross-sectional imaging; any implant revision was the key study endpoint. At 10-year follow-up, device survival for the entire cohort was 91%, with revision required in 10 men (6%) and 13 women (20%). The prevalence of ARM was 7% in male and 9% in female patients; it was associated with revision in 3 men (2%) and 8 women (9%). Pseudotumors were observed most commonly in symptomatic patients with elevated metal ion levels (63%) compared with asymptomatic patients with elevated metal ion levels (42%) and symptomatic patients with nonelevated metal ions (11%).
 
Summary of Evidence
The evidence for hip resurfacing in young active patients who would potentially outlive a traditional total hip prosthesis includes 2 randomized controlled trials, numerous large observational studies, large registry studies, and systematic reviews. Relevant outcomes are symptoms, change in disease status, quality of life, functional outcomes, health status measures, and treatment-related morbidity, change in disease status, and symptoms. The efficacy of total hip resurfacing (THR) performed with current techniques is similar to total hip arthroplasty (THA) over the short to medium term, and THR may allow for easier conversion to a THA for younger patients who are expected to outlive their prosthesis. Based on potential ease of revision when compared with THA, the evidence available at this time supports the conclusions that hip resurfacing (partial or total) presents a reasonable alternative for active patients who are considered too young for THA, when performed by surgeons experienced in the technique. The literature on adverse effects such as metallosis, pseudotumor formation, and implant failure is evolving as longer follow-up becomes available. Due to the uncertain risk with metal-on-metal implants (MoM), the risk/benefit ratio needs to be carefully considered on an individual basis. In addition, emerging evidence indicates an increased risk of failure in women, possibly due to smaller implant size. Therefore, these factors should also be considered in the overall patient evaluation for THR, and patients should make an informed choice in conjunction with their treating physicians. The evidence is sufficient to determine quantitatively that the technology results in a meaningful improvement in the net health outcome.
 
2017 Update
A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement.  
 
2018 Update
A literature search was conducted through August 2018.  There was no new information identified that would prompt a change in the coverage statement.      

CPT/HCPCS:
27130Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft
27299Unlisted procedure, pelvis or hip joint
S2118Metal-on-metal total hip resurfacing, including acetabular and femoral components

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