Early Feasibility Study of Cartilage Defect Repair for Hip Disease Using the ReNew Hip Implant

What this Trial Is About

Researchers are evaluating a new treatment option for patients aged 14 to 64 years who suffer from hip diseases that cause loss of cartilage integrity on the femoral head, such as femoroacetabular impingement or other structural deformities. These patients have not responded to conservative care and are candidates for surgical intervention. The study focuses on offering an alternative to total hip replacement, which is often unsuitable for younger, active individuals. The investigational treatment is the ReNew Hip Implant, a bioabsorbable, highly porous device designed to mimic healthy cartilage mechanically. This implant combines a biomimetic 3D woven textile with a porous 3D-printed framework and preserves healthy bone stock, allowing for future surgeries if needed. The implant is surgically placed to repair cartilage defects on the femoral head. Participants will be closely monitored through follow-up visits lasting up to five years after surgery. Researchers will assess safety by tracking adverse events and device-related serious adverse events, and effectiveness through pain and function measurements using tools like the international Hip Outcome Tool-33 (iHOT-33). Additional evaluations include radiographic imaging, patient-reported outcomes, and health economic measures at various time points up to 60 months.

Early Feasibility Study of Cartilage Defect Repair