Hydrogel coating to prevent infections after hip surgery
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
This study is testing whether a special hydrogel coating can help prevent infections after hip surgery for people getting a new hip implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05679232 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for cementless revision hip arthroplasty.
Not a fit: Patients with contraindications to the hydrogel components or those with active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections following hip replacement surgeries, leading to better patient outcomes and lower healthcare costs.
How similar studies have performed: While the use of antibacterial coatings is a promising area, the specific application of MectaShield in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.