Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

Launched by MEDACTA INTERNATIONAL SA · Jan 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new protective coating called MectaShield, which is applied to hip implants during surgery to help prevent infections after joint replacement surgery, specifically cementless revision hip arthroplasty. The goal is to see if this hydrogel coating can keep bacteria from sticking to the implants and to check if it affects the stability of the implant. Researchers will compare results from patients who receive the MectaShield treatment with those who do not, looking at infection rates and overall recovery.

To participate in this trial, you need to be at least 18 years old and scheduled for a specific type of hip surgery. You must be able to provide consent and follow the evaluation schedule before and after surgery. However, if you have certain medical conditions, allergies to the coating materials, or are undergoing emergency surgery, you may not be eligible. Participants can expect to receive care as per standard practice, and the study aims to ensure their safety while exploring this new approach to reducing infections after hip surgery.

Gender

ALL

Eligibility criteria

• 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
• • Subjects whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
• • Subjects affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity
• • Subjects unable to understand and take action
• • Subjects undergoing cementless revision hip arthroplasty in emergency interventions