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 r
| Condition(s) | Arthritis, Traumatic Arthritis, Avascular Necrosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * Informed Consent signed by the subject * Males and females aged over 18 years at time of surgery * Subjects who are scheduled to receive a conical collarless cementless revision hip arthroplasty, with or without revision of the acetabular cup * Subjects willing to comply with the pre- and post-operative evaluation schedule Exclusion Criteria: * Subjects with one or more medical conditions identified as a contraindication defined by the labelling on any implants used in this study * Subjects with immune suppressive treatment for organ transplantation, or known allergy to MectaShield hydrogel constituents (Chitlac, Mannitol, Hydroxypropylmethylcellulose, Sodium phosphate dibasic) * Subjects presenting with progressive local or systemic infection at the time of surgery * |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medacta International SA |
| Locations | Vienna, Austria |
| Start date | 2022-12-06 |
| NCT ID | NCT05679232 |
| Official listing | https://clinicaltrials.gov/study/NCT05679232 |