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Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

NCT05679232 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

  • Arthritis
  • Traumatic Arthritis
  • Avascular Necrosis

Interventions

DEVICE

Hydrogel coating

hydrogel coating applied to implant's surfaces during cementless hip revision arthroplasty

PROCEDURE

Control

standard cementless hip revision arthroplasty

Sponsors & Collaborators

  • Medacta International SA

    lead INDUSTRY

Principal Investigators

  • Martin Dominkus, Prof. Dr. · Orthopädisches Spital Speising GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2027-03-06
Completion
2027-12-06

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679232 on ClinicalTrials.gov