Hydrogel coating to prevent infections after hip surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation evaluates the safety and preliminary effectiveness of MectaShield hydrogel coating in preventing early peri-prosthetic joint infections (PJI) in patients undergoing cementless revision hip arthroplasty. Participants will be randomly assigned to receive either the hydrogel coating or standard care without it. The study aims to ensure that the hydrogel does not interfere with the stability of the implant while monitoring clinical outcomes and any adverse events over a follow-up period of 3 and 12 months. Data will be collected on functional outcomes, infection rates, and overall safety of the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Orthopädisches Spital Speising GmbH
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Martin Dominkus, Prof. Dr. — Orthopädisches Spital Speising GmbH
• Study coordinator: Marco Viganó, PhD
• Email: m.vigano@medacta.ch
• Phone: Pho: +41 91 696 60 60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.