Biomet, Inc. (Biomet), is planning to complete the trial named “A Comparison of Two Different Surgical Techniques to Preserve the Bony Supply and Improve Implant Longevity in Hip Resurfacing Arthroplasty” for ReCap Total Hip Resurfacing System by November 2013. The trial is currently recruiting participants. The study objective is to compare two different surgical techniques in hip resurfacing arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as implant migration, periprosthetic bone mineral density, gait function and patient recovery.
The randomized, single blind (subject), parallel assignment, efficacy study is conducted in Denmark with the estimated enrollment of 50 subjects.
The Recap is a bone conserving resurfacing system designed for the early stages of degenerative joint disease patients. Unlike traditional total hip replacement where the entire hip joint is replaced, the ReCap Resurfacing System is designed to be more bone-sparing and replacing only the diseased or damaged surfaces of the hip joint. The Recap system includes two components such as an acetabular and femoral component. The acetabular component (also called a cup or shell) is pressed into the cup shaped area of pelvic bone. This component has a roughened surface (called PPS titanium porous plasma spray), which promotes bone in-growth on the component surface. The femoral component is placed into the top part of thighbone (femur) and anchored by the use of bone cement. This femoral component has a central post, which is shorter than a traditional femoral stem. Both components have highly polished surfaces where they contact each other to re-create the ball and socket hip joint.