Over the last decade, use of large-diameter femoral heads has minimized dislocation risk in total hip arthroplasty. Despite the benefits of improved stability, these larger heads may impinge on native soft tissues, leading to anterior hip or groin pain post-operatively. 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 design provides a smooth transition throughout the femoral head and the head-neck junction.

Pre-clinical testing of the implant shows that the anatomically contoured design retains the same joint stability and dislocation resistance as currently available head designs. BIOLOX CONTOURA® has been cleared by the FDA for use with Total Joint Orthopedics’ Klassic HD® Hip System, which is intended for prosthetic replacement without bone cement across a range of conditions, including non-inflammatory degenerative joint disease, rheumatoid arthritis, hip dysplasia, and revision of previously failed hip arthroplasty.

A new, anatomically contoured ceramic femoral head is providing surgeons with additional options to restore hip joint biomechanics. After FDA clearance in August, the BIOLOX CONTOURA® head was implanted by George N. Guild, III, MD in a hip replacement procedure at Emory University in September.

“The Contoura head is the first innovation in femoral head design we’ve seen in total hip replacement,” said Dr. Guild. “Small refinements can have a big impact on patient outcomes and I look forward to the potential improvements this product may offer.”

Distributed and marketed by Total Joint Orthopedics, Inc., the innovative femoral head made of BIOLOX® delta ceramic material was conceived and developed at the Harris Orthopedics Laboratory at Massachusetts General Hospital in Boston by Drs. Orhun Muratoglu, Kartik M. Varadarajan, Harry Rubash, Henrik Malchau, and Andrew Freiberg in cooperation with CeramTec, supplier of the BIOLOX® delta advanced ceramics.

According to Orhun Muratoglu, PhD, Director of the Harris Orthopaedics Laboratory, Director of the Technology Implementation Research Center (TIRC) and Alan Gerry Scholar at MGH, and Professor of Orthopedic Surgery at Harvard Medical School, partnering with CeramTec and Total Joint Orthopedics was fruitful. He added, “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.”

Research on the implant began in 2012, led by Drs. Muratoglu and Kartik Mangudi Varadarajan, PhD, Associate Director for the TIRC at MGH, and Assistant Professor of Orthopedic Surgery at Harvard, together with Drs. Rubash, Malchau, and Freiberg. The research team worked with Partners HealthCare Innovation, the business development unit of Partners, and partnered with CeramTec to design and test the anatomically contoured ceramic head. The collaboration with Total Joint Orthopedics brought the implant to market for clinical use.

References:
Large diameter heads, is bigger always better? Rodriguez J. A. and Rathod P. A. The Journal of Bone and Joint Surgery. British volume 2012 94-B:11_Supple_A, 52-54 https://doi.org/10.1302/0301-620X.94B11.30508

Next-generation soft-tissue-friendly large-diameter femoral head, Kartik Mangudi Varadarajan, Michael P. Duffy, Thomas Zumbrunn, David Chan, Keith Wannomae, Brad Micheli, Andrew A. Freiberg, Harry E. Rubash, Henrik Malchau, Orhun K. Muratoglu, Seminars in Arthroplasty, Volume 24, Issue 4, 2013, Pages 211-217, ISSN 1045-4527, https://doi.org/10.1053/j.sart.2014.01.007

Anatomically contoured large femoral heads can reduce iliopsoas impingement: A cadaver verification study, Kartik Mangudi Varadarajan, Thomas Zumbrunn, Michael P. Duffy, Rajan Patel, Harry E. Rubash, Henrik Malchau, Orhun K. Muratoglu, Andrew A. Freiberg, Seminars in Arthroplasty, Volume 26, Issue 1, 2015, Pages 28-33, ISSN 1045-4527, https://doi.org/10.1053/j.sart.2015.04.006