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Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

Study acronym: BEAR
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Dec 9, 2025, no change to tracked fieldsv17-v18
  2. Primary completion date: Feb 2016 to Mar 19, 2018
    • Study completion date: Feb 2025 to Dec 31, 2026
    v16
  3. Study completion date: Feb 2024 to Feb 2025v15
  4. Phase: Phase 1 to Not applicablev14
  5. Lead sponsor: Martha Murray to Miach Orthopaedicsv13 Show 5 more changesShow less
    • Primary endpoint revised
    • Trial status: Completed to Active, Not Recruiting
    • Study completion date: Nov 2016 to Feb 2024
    • Secondary endpoints revised (5)
    • Collaborators shortened, about 3 words
Show 11 earlier versionsHide 11 earlier versions
  1. 3 versions Re-verified since Apr 20, 2017, no change to tracked fieldsv10-v12
  2. Lead sponsor: [Redacted] to Martha Murrayv9 Show 6 more changesShow less
    • Trial status: Withheld to Completed
    • Primary completion date: Feb 2016
    • Study completion date: Nov 2016
    • Start date: Jan 2015
    • Study title shortened, about 7 words
    • Collaborators expanded, about 3 words
  3. 7 versions Re-verified since Jan 14, 2015, no change to tracked fieldsv2-v8
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)
Trial Details
NCT Number NCT02292004
Lead Sponsor Miach Orthopaedics
Conditions
(from sponsor)		 Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear
Related terms Anterior Cruciate Ligament Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov