CytexOrtho has earned FDA approval to begin a clinical trial evaluating the safety and efficacy of its absorbable hip implant in human patients, according to an Oct. 29 report from Mass Device.
The ReNew hip implant uses 3D manufacturing and polycaprolactone to help hip disease patients who do not need a full hip joint replacement.
While there are over one million Americans under 65 with chronic hip pain, approximately only 20% get hip replacements, according to the report.
Under the FDA investigational device exemption, CytexOrtho will conduct a non-randomized, single-arm study with up to 15 patients who have hip disease resulting in the loss of articular cartilage integrity on the femoral head.
The study will establish an initial safety profile and evaluate patient improvement and function over a 12-month period. It will continue tracking patients for five years after implantation.
The company aims to have FDA pre-market approval for the ReNew hip in late 2028 or 2029.