Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

NCT05679232 · tracked via the Priya Life Science Austria tracker

Sponsor

Medacta International SA

Phase

Not applicable

Started

2022-12-06

Last updated

2025-05-11

Condition(s) studied

ArthritisTraumatic ArthritisAvascular Necrosis

Investigational drug(s) / intervention(s)

Hydrogel coatingControl

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

Control: standard cementless hip revision arthroplasty

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Stem subsidence — 3 months follow up
Radiological measurements of stem subsidence (mm) will be performed in hydrogel coating and control groups, and mean subsidence will be compared

Trial sites (1)

Facility	City	Region	Status
Orthopädisches Spital Speising GmbH	Vienna	Austria	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05679232 on ClinicalTrials.gov ↗ ← All trials in Austria