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New treatment option for Arthritis
Official title Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
ClinicalTrials.gov ID: NCT05679232
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed Consent signed by the subject
- Males and females aged over 18 years at time of surgery
- people who are scheduled to receive a conical collarless cementless revision hip arthroplasty, with or without revision of the acetabular cup
- people willing to comply with the pre- and post-operative evaluation schedule
You likely can't join if
- people with one or more medical conditions identified as a contraindication defined by the labelling on any implants used in this study
- people with immune suppressive treatment for organ transplantation, or known allergy to MectaShield hydrogel constituents (Chitlac, Mannitol...
- people presenting with progressive local or systemic infection at the time of surgery
- people whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- people affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity
- people unable to understand and take action
See the full eligibility criteria
- Informed Consent signed by the subject
- Males and females aged over 18 years at time of surgery
- people who are scheduled to receive a conical collarless cementless revision hip arthroplasty, with or without revision of the acetabular cup
- people willing to comply with the pre- and post-operative evaluation schedule
- people with one or more medical conditions identified as a contraindication defined by the labelling on any implants used in this study
- people with immune suppressive treatment for organ transplantation, or known allergy to MectaShield hydrogel constituents (Chitlac, Mannitol, Hydroxypropylmethylcellulose, Sodium phosphate dibasic)
- people presenting with progressive local or systemic infection at the time of surgery
- people whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- people affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity
- people unable to understand and take action
- people undergoing cementless revision hip arthroplasty in emergency interventions
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.