ArthritisNCT05679232
Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
A study testing Hydrogel coating in people with Arthritis and Traumatic Arthritis, run by Medacta International SA at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Traumatic Arthritis, Avascular Necrosis
- What is being tested?
- Hydrogel coating
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteAustria
- Study dates
- 6 Dec 2022to 6 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Orthopädisches Spital Speising GmbH
Vienna, 1130
Martin Dominkus, Prof. Dr., +43 1 80182 1182, martin.dominkus@oss.at
About this study
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
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:
Read more
- 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.
Read the 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:
- To demonstrate that MectaShield does not interfere with primary stability at 12 months of follow-up
- To evaluate clinical and functional outcomes at 3 and 12 months of follow-up
- To evaluate the rate of PJI at 3 and 12 months of follow-up
- To evaluate the occurrence of adverse events and device deficiencies
- Conditions
- Arthritis, Traumatic Arthritis, Avascular Necrosis
- Being tested
- Hydrogel coating, Control
- Medical subject headings
- Arthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel coatingDevice
hydrogel coating applied to implant's surfaces during cementless hip revision arthroplasty
ControlProcedure or surgery
standard cementless hip revision arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Hydrogel coating | Experimental | cementless revision hip arthroplasty with hydrogel coating applied on orthopaedic implants' surfaces Receives: Device: Hydrogel coating |
| Control | Sham comparator | cementless revision hip arthroplasty Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem subsidence
Radiological measurements of stem subsidence (mm) will be performed in hydrogel coating and control groups, and mean subsidence will be compared
Measured: 3 months follow up
Secondary outcomes (9)
Stem subsidence
Radiological measurements of stem subsidence (mm) will be performed in hydrogel coating and control groups, and mean subsidence will be compared.
Measured: 12 months follow up
Presence of radiolucent zones in the femur
Presence of radiolucent lines (≥1 mm) in the 7 Gruen zones will be assessed by radiologic assessment.
Measured: 3 and 12 months follow up
Cup migration (if revised)
Radiological measurements will be performed on the Acetabular cup (if revised) to measure cup migration.
Measured: 3 and 12 months follow up
Cup orientation (if revised)
Radiological measurements will be performed on the Acetabular cup (if revised) to measure cup tilt.
Measured: 3 and 12 months follow up
Presence of radiolucent lines in the acetabular cup (if revised)
Radiological measurements will be performed on the Acetabular cup (if revised) to evaluate the presence of radiolucent lines in the 3 DeLee-Charnley zones (≥1mm).
Measured: 3 and 12 months follow up
Clinical and functional outcomes
Evaluation of daily-life activities, measured with the Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS) [0 - 100, worst to best].
Measured: 3 and 12 months follow up
Signs of infection
Evaluation of any sign of infection at the site of surgery, measured with the ASESPIS score (acronym for "Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient prolonged over 14 days") [0 - >40, best to worst].
Measured: 3 and 12 months follow up
occurrence of PJI
The occurrence of PJI is assessed with the diagnostic flowchart proposed by the consensus document issued by the 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).
Measured: up to 12 months
Peri-operative and postoperative adverse events and device deficiencies.
Monitoring of any peri-operative and postoperative adverse events and device deficiencies.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start6 Dec 2022
- Primary completion6 Mar 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Dominkus, Prof. Dr., Principal investigator, Orthopädisches Spital Speising GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679232
- Sponsor's protocol ID
- P01.025.01
- Status last verified
- Oct 2026
- First submitted
- 21 Dec 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No