Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the prevention of early peri-prosthetic joint infection (PJI) in patients undergoing cementless revision hip arthroplasty. The main questions it aims to answer are: * demonstrate that the hydrogel coating MectaShield does not interfere with primary stability; * evaluate clinical and functional outcomes, the rate of PJI and possible adverse events. Participants will undergo cementless revision hip arthroplasty; during surgery MectaShield hydrogel coating is applied on orthopaedic implants' surfaces (femoral stem and, if revised, acetabular cup) as a protective barrier for the prevention of bacterial adhesion. Surgery and follow-up are completed as per local standard practice. Stability will be assessed radiologically, while functional outcomes and PJI will be monitored by HOOS-PS, ASESPIS scores and according to the consensus document presented by European Society of Radiology (ESRa), the European Association of Nuclear Medicine (EANM), the European Bone and Joint Infection Society (EBJIS), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Researchers will compare the results of the treatment group with those from a control group receiving cementless revision hip arthroplasty without the application of MectaShiled hydrogel coating.

NCT Number	NCT05679232
Lead Sponsor	Medacta International SA
Conditions	Arthritis, Traumatic Arthritis, Avascular Necrosis
Enrollment	56 participants
Start Date	2022-12-06
Primary Completion	2027-03-06 (estimated)
Study Completion	2027-12-06 (estimated)
Updated on ClinicalTrials.gov	2025-05-11