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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Orthopädisches Spital Speising GmbH
RECRUITING
Vienna
Contact Information
Primary
Marco Viganó, PhD
m.vigano@medacta.ch
Pho: +41 91 696 60 60
Time Frame
Start Date: 2022-12-06
Estimated Completion Date: 2027-12-06
Participants
Target number of participants: 56
Treatments
Experimental: Hydrogel coating
cementless revision hip arthroplasty with hydrogel coating applied on orthopaedic implants' surfaces
Sham_comparator: Control
cementless revision hip arthroplasty
Related Therapeutic Areas
Sponsors
Leads: Medacta International SA

This content was sourced from clinicaltrials.gov