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A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 9 to 8v15
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v14
  3. Enrollment target: 750 to 300
    • Site details revised at 7 of 9 sites
    v13
  4. Study sites: 8 to 9v12
  5. Study sites: 6 to 8v11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 2 of 6 sitesv10
  2. Study sites: 3 to 6v9
  3. Study sites: 2 to 3v8
  4. Re-verified, no change to tracked fieldsv7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date: Feb 6, 2023 to Feb 28, 2023
    v6
  6. Start date: Sep 30, 2022 to Feb 6, 2023
    • Study sites: 0 to 1
    • Primary completion date: Jun 30, 2026 to Oct 30, 2026
    • Study completion date: Dec 30, 2026 to Jan 30, 2027
    v5
  7. Start date: Jun 30, 2022 to Sep 30, 2022v4
  8. Eligibility criteria shortened, about 7 words
    • Study description shortened, about 7 words
    v3
  9. Secondary endpoints revised (7)v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
Trial Details
NCT Number NCT05398341
Lead Sponsor Miach Orthopaedics
Conditions
(from sponsor)		 Anterior Cruciate Ligament Injuries
Related terms Anterior Cruciate Ligament Injuries
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov