Randomized Controlled Study to Assess Safety and Performance of MectaShield Hydrogel Coating to Reduce Infection After Cementless Revision Hip Arthroplasty

What this Trial Is About

Researchers are evaluating the safety and early clinical performance of MectaShield, a hydrogel coating designed to prevent infections after cementless revision hip arthroplasty. This randomized, controlled, single-blind study aims to determine whether the coating affects implant stability and to assess clinical outcomes, rates of infection, and any adverse events. The study addresses the serious issue of peri-prosthetic joint infection (PJI), a common cause of joint replacement failure that can lead to repeated surgeries and prolonged hospital stays. Participants will undergo cementless revision hip arthroplasty, with half receiving the MectaShield hydrogel coating applied to the surfaces of the orthopedic implants during surgery, while the control group will have surgery without the coating. The coating acts as a protective barrier against bacterial adhesion. The study includes two groups randomized equally, and follow-up visits are scheduled at 3 and 12 months after surgery to monitor implant stability, infection signs, and functional outcomes. During the study, participants will have clinical and functional assessments before and after surgery, with radiological evaluations to check implant stability and positioning. Infection will be monitored using established scoring systems and consensus guidelines. Researchers will track adverse events and device performance throughout the 12-month follow-up. The main outcome is stem subsidence at 3 months, with additional measurements and evaluations at 12 months to assess longer-term safety and effectiveness.

Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty