An interventional study of Hydrogel coating and Control in Arthritis, Traumatic Arthritis and Avascular Necrosis, sponsored by Medacta International SA. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Medacta International SA · Not applicable, Interventional, and Prevention
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:
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.
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:
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:
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 56 is below the median of 97 across 599 interventional studies indexed under Arthritis.
Browse Arthritis studies →Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cementless revision hip arthroplasty with hydrogel coating applied on orthopaedic implants' surfaces
Device: Hydrogel coating
cementless revision hip arthroplasty
Procedure: Control
hydrogel coating applied to implant's surfaces during cementless hip revision arthroplasty
standard cementless hip revision arthroplasty
Stem subsidence
Radiological measurements of stem subsidence (mm) will be performed in hydrogel coating and control groups, and mean subsidence will be compared
Time frame: 3 months follow up
Stem subsidence
Radiological measurements of stem subsidence (mm) will be performed in hydrogel coating and control groups, and mean subsidence will be compared.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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) \[0 - 100, worst to best\].
Time frame: 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") \[0 - \>40, best to worst\].
Time frame: 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).
Time frame: 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.
Time frame: up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Mar 2027, 51 months after the start.
Of 167 interventional studies with no phase under Arthritis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 65. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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