Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
Randomized, Controlled, Monocentric, Feasibility Clinical Investigation to Assess the Safety and Preliminary Clinical Performance of a Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
Medacta International SA
56 participants
Dec 6, 2022
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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
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Interventions
hydrogel coating applied to implant's surfaces during cementless hip revision arthroplasty
standard cementless hip revision arthroplasty
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05679232