Total Joint Orthopedics (TJO) announced the first implantation of the new BIOLOX CONTOURA® femoral head following FDA 510(k) clearance in 3Q19.
The device, made of BIOLOX® delta ceramic material, is distribued and marketed by TJO and was developed at the Harris Orthopedics Laboratory at Massachusetts General Hospital in cooperation with CeramTec, supplier of BIOLOX delta advanced ceramics. Research commenced in 2012, with CeramTec providing design and testing services.
Orhun Muratoglu, Ph.D., Director of the Harris Orthopaedics Lab, said that partnering with CeramTec and TJO was fruitful, adding, “By creating an innovative alternative design that seeks to address hip dislocation concerns, we’re able to offer surgeons and their patients a viable implant option that might also reduce the pressure on soft tissue.”
Over the last decade, use of large-diameter femoral heads has minimized dislocation risk in total hip replacement. Despite benefits of improved stability, these larger heads may impinge on native soft tissues, leading to post-op anterior hip or groin pain. To counteract potential impingement, BIOLOX CONTOURA implants retain the outer diameter profile of conventional implants and incorporate a contoured shoulder with a lesser radius to reduce the volume of material exposed to the soft tissue. This provides a smooth transition throughout the femoral head and the head/neck junction.
Pre-clinical testing demonstrated that the contoured design retains the same joint stability and dislocation resistance as currently available heads. The BIOLOX CONTOURA head is FDA-cleared for use with the TJO's cementless Klassic HD® Hip, which is intended for hip replacement to treat a range of conditions, including non-inflammatory degenerative joint disease, rheumatoid arthritis, hip dysplasia and revision procedures.
George N. Guild, III, M.D., the surgeon who performed the first implantation of the new head in September, said, “The Contoura head is the first innovation in femoral head design we’ve seen in total hip replacement. Small refinements can have a big impact on patient outcomes and I look forward to the potential improvements this product may offer.”
|The BIOLOX CONTOURA Head|