Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

NCT ID
NCT05679232
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Medacta International SA
Conditions
Arthritis, Avascular Necrosis, Traumatic Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 56 participants (Estimated).

What is being studied

  • Procedure: Control
  • Device: Hydrogel coating

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Austria

Sample of listed locations

  • Orthopädisches Spital Speising GmbH — Vienna, 1130, Austria — Recruiting

Study details

Start date
December 6, 2022
Primary completion date
March 6, 2027
Completion date
December 6, 2027
First posted
January 10, 2023

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05679232
Registry last updated
October 7, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT05679232 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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