Status: Decision completed
Policy context
Metal-on-metal (MoM) bearing safety concerns: MoM hip systems, both total hip arthroplasty (THA) and hip replacement (HR), have received widespread usage. As a result, more information has become available regarding the safety profile and clinical performance of these systems. Data from national total joint registries, as well as, peer-reviewed journal publications and presentations at scientific meetings have suggested increases in potential safety issues associated with MoM hip systems to include:
- Local complications such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions (ALVAL).
- Early device failure and the need for revision surgery.
- Systemic complications from metal ion exposure.
Primary criteria ranking
- Safety = High
- Efficacy = Medium
- Cost = Medium
- Documents (all assessments)
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Assessment (2013)
Update literature (2012)
Assessment (2009)
Assessment timeline (2013)
- Draft key questions published: May 23, 2013
- Public comment period: May 23 to June 7, 2013
- Draft report published: August 27, 2013
- Public comment period: August 27 to September 26, 2013
- Final report published: October 1, 2013
- HTCC public meeting: November 15, 2013
Background
Patients with joint pain and dysfunction caused by noninflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia, or inflammatory arthritis such as rheumatoid arthritis, may be treated with hip replacement technologies including hip resurfacing (HR). Hip resurfacing is proposed as a bone conserving alternative to the conventional total hip replacement or arthroplasty (THA) after more conservative medical therapy fails.
Unlike THA, HR does not involve the removal of the femoral head and neck or removal of bone from the femur. Rather, the head, neck and femur bone is preserved in an effort to facilitate future surgery should it be necessary, and to enable the patient to take advantage of newer technology or treatments in the future. Hip resurfacing is anatomically and biomechanically more similar to the natural hip joint. FDA approved devices in the USA include metal-on-metal (MoM) bearing surfaces.
Proposed benefits of hip resurfacing include increased stability, flexibility and range of motion. Additionally, younger patients needing full joint replacement that are expected to out-live the full replacement may benefit from symptom relief and more bone preservation to tolerate a subsequent replacement surgery.