The Metal-on-Metal Hip Resurfacing on a Profounder View
The California Technology Assessment Forum(CTAF) published an assessment paper on October 19, 2011 raising a critical view on all-metal resurfacing. In 2010, the CTAF made an assessment on the same topic, and this paper entitled "Metal on Metal Hip Resurfacing as an Alternative to Total Hip Arthroplasty", is an update.The forum finds that metal-on-metal hip resurfacing too risky. CTAF is a group of people with shared dedication of objective and transparent medical technologies. It is a place for talks and decisions on the safety and effectiveness of the latest and upcoming technologies.After the Food and Drug Administration mandated an emergency study on patients of all-metal hips, CTAF reassessed the involved implants. Included in the reassessment are the Birmingham Hip Resurfacing (BHR) system, the Cormet 2000 Hip Resurfacing System, and the Wright Medical Technologies Conserve Plus Hip System. Other hip resurfacing hip devices had been developed, but only these three were approved by the FDA. There were five criteria judged by the group to be required to provide assurance of safety of these systems: 1. The technology must have final approval from the appropriate government regulatory bodies.
2. The scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes.
3. The technology must improve net health outcomes.
4. The technology must be as beneficial as any established alternatives.
5. The improvement must be attainable outside of the investigational setting.Only two out of five criteria were met by the assessed MoM hip resurfacing system. Because the FDA gave approval to the device and multiple random control tests were also conducted, the first two TA criteria were met. Hip resurfacing arthroplasty (HRA) may pose some benefits, but it is not free of potential risks. Compared to total hip replacement (THR), HRA has higher revision rates. From this, the third TA criteria is not met, likewise, the fourth and the fifth. The CTAF concluded that "It is incumbent upon the hip resurfacing community to prove the efficacy and safety of [metal-on-metal] hip resurfacing in randomized clinical trials, rather than subjecting young patients to significant potential harm over their lifetimes." Other groups are also planning to take a closer look at resurfacing. Among these orthopedic authorities are the Australian orthopedic registry, the American Academy of Orthopedic Surgeons and the National Joint Registry of England and Wales. Both THR and HRA pose complications that may result to hip replacement recall. Hence, consulting a health care professional is essential, coupled with adequate research on the procedure.
2. The scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes.
3. The technology must improve net health outcomes.
4. The technology must be as beneficial as any established alternatives.
5. The improvement must be attainable outside of the investigational setting.Only two out of five criteria were met by the assessed MoM hip resurfacing system. Because the FDA gave approval to the device and multiple random control tests were also conducted, the first two TA criteria were met. Hip resurfacing arthroplasty (HRA) may pose some benefits, but it is not free of potential risks. Compared to total hip replacement (THR), HRA has higher revision rates. From this, the third TA criteria is not met, likewise, the fourth and the fifth. The CTAF concluded that "It is incumbent upon the hip resurfacing community to prove the efficacy and safety of [metal-on-metal] hip resurfacing in randomized clinical trials, rather than subjecting young patients to significant potential harm over their lifetimes." Other groups are also planning to take a closer look at resurfacing. Among these orthopedic authorities are the Australian orthopedic registry, the American Academy of Orthopedic Surgeons and the National Joint Registry of England and Wales. Both THR and HRA pose complications that may result to hip replacement recall. Hence, consulting a health care professional is essential, coupled with adequate research on the procedure.