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AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

Study acronym: REPAIR
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Jan 1, 2026 → Jun 1, 2027
See other at-risk trials from McMaster University

Record History

  1. Primary completion pushed from Jan 1, 2026 to Jun 1, 2027 Completion pushed from Jan 1, 2027 to Dec 1, 2027 · Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 3 of 4 entries Show 3 more changesShow less
    • Completion pushed from Jan 1, 2027 to Dec 1, 2027
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Re-verified, no change to tracked fieldsv4
  3. Secondary endpoints revised (4) Eligibility criteria shortened, about 4 wordsv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 30 to 40 · Study sites: 0 to 1 · Start date changed from estimate of Jan 1, 2023 to Mar 13, 2023v2 Show 3 more changesShow less
    • Enrollment target: 30 to 40
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 1, 2023 to Mar 13, 2023
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a pilot multi-centre RCT of 40 patients (ages 18-55 years, inclusive) undergoing primary hip arthroscopy with a focal articular cartilage defect of the acetabulum to compare the effect of using autologous matrix-induced chondrogenesis (AMIC) in comparison to microfracture on hip function, health-related quality of life, hip pain, cartilage regeneration, health utility, and any adverse events at 2 years. Follow-up will occur at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery.
Trial Details
NCT Number NCT05402072
Lead Sponsor McMaster University
Collaborators: Geistlich Pharma AG
Conditions Hip Arthroscopy, Articular Cartilage Defect, Microfractures
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov