Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

NCT05679232 | Recruiting

• 1 other identifier: P01.025.01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stem subsidence

  Radiological measurements of stem subsidence (mm) will be performed in hydrogel coating and control groups, and mean subsidence will be compared

  3 months follow up

Secondary Outcomes (9)

• Stem subsidence

  12 months follow up

• Presence of radiolucent zones in the femur

  3 and 12 months follow up

• Cup migration (if revised)

  3 and 12 months follow up

• Cup orientation (if revised)

  3 and 12 months follow up

• Presence of radiolucent lines in the acetabular cup (if revised)

  3 and 12 months follow up

Study Arms (2)

Hydrogel coating

EXPERIMENTAL

cementless revision hip arthroplasty with hydrogel coating applied on orthopaedic implants' surfaces

Device: Hydrogel coating

Control

SHAM COMPARATOR

cementless revision hip arthroplasty

Procedure: Control

Interventions

Hydrogel coating DEVICE

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

Hydrogel coating

Control PROCEDURE

standard cementless hip revision arthroplasty

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Orthopädisches Spital Speising GmbH

Vienna, 1130, Austria

RECRUITING

MeSH Terms

Conditions

Arthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Dominkus, Prof. Dr.

  Orthopädisches Spital Speising GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Viganó, PhD

CONTACT

Pho: +41 91 696 60 60; m.vigano@medacta.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study requires a blinded evaluator for the assessment of the primary outcome (i.e. radiological signs of failed osseointegration). The investigators and the participating patients are not blinded to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 10, 2023
• Study Start: December 6, 2022
• Primary Completion (Estimated): March 6, 2027
• Study Completion (Estimated): December 6, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)