Authors' objectives:

"To evaluate available evidence on the benefits and harms of HR as an alternative to THA in comparable patients. The Assessment will consider relative symptomatic and functional improvement, and complications of HR. Key considerations are the durability of HR reflected by revision rates due to joint failure. Throughout the Assessment, unless otherwise indicated, it will be assumed "HR" and "THA" refer to the use of MoM prostheses." (from executive summary)

Authors' recommendations: A substantial body of evidence shows HR is associated with consistent and strong symptomatic and functional improvements at follow-up times up to 5 years. HR results are comparable to those obtained with current generation THA at similar time points in patients younger than 65 years of age. HR differs procedurally from THA in conserving a patient's native femoral bone neck. When HR patients subsequently require revision to THA, the operation is technically similar to primary THA and likely avoids the complications of revision of a primary THA. Thus, the benefits comprise initial HR results as good as THA and a simpler revision to THA when needed. Although longer-term (i.e., greater than 5 years) data on the relative durability of HR compared to THA are unavailable, current evidence is sufficient to conclude that HR is a safe and effective means for initial surgical treatment in younger, properly selected patients who require a total hip replacement. Primary use of HR in the indicated patient subpopulation thus defers standard THA. Based on the available direct and indirect evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether HR meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental regulatory bodies. The Birmingham Hip Resurfacing (BHR) System was approved for marketing by FDA on May 9, 2006. It is a single-use device, intended for hybrid fixation, using a cemented femoral head component and cementless acetabular component, intended for use in patients who require primary HR arthroplasty due to non-inflammatory arthritis (DJD) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia; or inflammatory arthritis such as rheumatoid arthritis. The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional THA due to increased possibility of requiring future ipsilateral hip joint revision. Two other Class B, non-experimental MoM hip resurfacing devices have received investigational device exemptions. The Cormet Hip Resurfacing System (Corin Medical) was deemed approvable with conditions by an FDA Advisory Panel February 22, 2007; a final FDA decision was not available at the time of this writing. The Conserve Plus Total Resurfacing Implant (Wright Medical Technology) may be considered for approval sometime in 2007. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. Evidence for the safety and efficacy of HR is available from more than 14,000 cases with mean follow-up times up to 5 years. Published series of THA using current-generation MoM prostheses (n=526) provide indirect evidence to compare HR and THA in patients younger than 65 years of age. Older series with longer follow-up of first-generation MoM THA (n=1,646) provide guidance on the potential durability of MoM prostheses. However, as the older series include prostheses that are outdated and no longer in clinical use, complications and revision rates may be overestimated and any comparisons must be viewed cautiously. Nonetheless, taken together, sufficient direct and indirect scientific evidence exists to permit conclusions about symptomatic and functional benefits of HR in properly selected patients for whom hip replacement is indicated. 3. The technology must improve the net health outcome 4. The technology must be as beneficial as any established alternatives. Key Assessment Question: Does HR improve health outcomes, such as pain, joint function, and activities of daily living, among patients with DJD who require hip replacement and are likely to outlive a traditional prosthesis, compared with THA. A single RCT with 1 year of follow-up provides good direct comparative evidence that HR improves the net health outcome and is as beneficial as THA in comparable patient samples. Additional data from uncontrolled series, the BHR FDA submission, and the AOA Registry, with indirect comparisons to THA, support these conclusions. Thus, the total body of evidence outlined in this Assessment is sufficient in magnitude of change and consistency of direction to conclude that HR improves the net health outcome and is as beneficial as THA in properly selected individuals who require a total hip replacement and, because of younger age and/or higher activity levels, are likely to outlive the 10 years or more functional lifespan of a traditional prosthetic device. Because HR leaves the femoral bone head and neck largely intact, subsequent revision to THA is typically less complicated than a procedure to replace a primary THA. Therefore, based on published clinical experience with improved current generation MoM THA, and similar 5-year survivorship rates, HR represents a safe and effective means to defer a first THA in properly selected patients who require a total hip replacement and are subsequently likely to require replacement of the ipsilateral hip due to normal wear processes. 5. The improvement must be attainable outside the investigational settings. Evidence for the safety and effectiveness of HR comes from a range of settings including the device designers and individual practitioners worldwide. An ongoing clinical training program for U.S. orthopedic surgeons is available from the manufacturer of the FDA-approved BHR System and its establishment was a condition of FDA marketing approval. Given this, it may be concluded that clinical benefits of HR will be attainable outside the investigational settings. Based on the above, use of an FDA-approved metal-on-metal total hip resurfacing device as an alternative to THA in patients who are likely to outlive the 10 years or more functional lifespan of a traditional MoM prosthesis meets the TEC criteria.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)