Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-28 @ 9:03 PM
Study NCT ID:
NCT05679232
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
Sponsor:
Medacta International SA
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Peri-prosthetic joint infection (PJI) is among the first three reasons for joint replacement failure. PJI is a serious condition that may lead to repeated surgical interventions, prolonged hospitalization, high costs, and significant morbidity, although low mortality. To address this concern, antibacterial coating of implants has been proposed, as the adherence of the microorganisms to the implant, forming a biofilm, plays a strategic role in the pathogenesis of PJI. MectaShield (Medacta International SA) is a novel resorbable hydrogel coating intended to be spread on orthopaedic implants' surfaces as a protective barrier for the prevention of PJI. The study aims to evaluate the safety of MectaShield and to capture its preliminary clinical performance in the prevention of early PJI in patients undergoing cementless revision hip arthroplasty.
Patients suitable to receive MectaShield for cementless revision hip arthroplasty will be invited to take part to the study during the preoperative visit. Follow-up is performed after 3 and 12 months. Data collection includes clinical and functional data for preoperative and postoperative assessments, as well as intraoperative details, adverse events and device deficiencies. Patients will be randomized 1:1 in 2 groups:
* Control (no MectaShield)
* MectaShield hydrogel coating (+ antibiotic)
The primary objective is to demonstrate that MectaShield hydrogel coating does not interfere with early primary stability at 3 months of follow-up
Secondary objectives are:
1. To demonstrate that MectaShield does not interfere with primary stability at 12 months of follow-up
2. To evaluate clinical and functional outcomes at 3 and 12 months of follow-up
3. To evaluate the rate of PJI at 3 and 12 months of follow-up
4. To evaluate the occurrence of adverse events and device deficiencies
Patients suitable to receive MectaShield for cementless revision hip arthroplasty will be invited to take part to the study during the preoperative visit. Follow-up is performed after 3 and 12 months. Data collection includes clinical and functional data for preoperative and postoperative assessments, as well as intraoperative details, adverse events and device deficiencies. Patients will be randomized 1:1 in 2 groups:
* Control (no MectaShield)
* MectaShield hydrogel coating (+ antibiotic)
The primary objective is to demonstrate that MectaShield hydrogel coating does not interfere with early primary stability at 3 months of follow-up
Secondary objectives are:
1. To demonstrate that MectaShield does not interfere with primary stability at 12 months of follow-up
2. To evaluate clinical and functional outcomes at 3 and 12 months of follow-up
3. To evaluate the rate of PJI at 3 and 12 months of follow-up
4. To evaluate the occurrence of adverse events and device deficiencies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: