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Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 11 words Secondary endpoints: details revised at 2 of 9 entries · Study description expanded, about 6 words Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 9 entries
    • Study description expanded, about 6 words
  2. Primary completion date: Dec 6, 2024 to Mar 6, 2027 Completion date: Dec 6, 2024 to Dec 6, 2027v3 Show 1 more changeShow less
    • Completion date: Dec 6, 2024 to Dec 6, 2027
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05679232
Lead Sponsor Medacta International SA
Conditions Arthritis, Traumatic Arthritis, Avascular Necrosis
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov