Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrogel coating
Devicehydrogel coating applied to implant's surfaces during cementless hip revision arthroplasty
Control
Procedure/Surgerystandard cementless hip revision arthroplasty
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Hydrogel coatingExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 upSecondary outcomes
1
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 up2
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 up3
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 up4
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 upSponsors and contacts
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Source ClinicalTrials.gov