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Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

RecruitingNAAges 18 Years - anyAllMedacta International SA
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Hydrogel coating
  • Control
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Where

1 site
Orthopädisches Spital Speising GmbH
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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