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Bridge-Enhanced ACL Repair vs ACL Reconstruction

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Primary completion date: Jun 2020 to Jun 19, 2019
    • Study completion date: May 2028 to May 31, 2028
    v12
  3. Results first posted: Jan 10, 2024
    • Primary endpoints revised (2)
    • Secondary endpoints: 4 to 2
    v11
  4. Primary completion date changed from estimate of May 2020 to Jun 2020v10
  5. Lead sponsor: Boston Children's Hospital to Miach Orthopaedicsv9
Show 7 earlier versionsHide 7 earlier versions
  1. 2 versions Re-verified since Dec 15, 2017, no change to tracked fieldsv7-v8
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  3. Interventions: BEAR Scaffold (Device), Suture Repair of the Anterior Cruciate Ligament (Procedure), Tendon Graft (Procedure) to BEAR Scaffold (Device), Tendon Graft (Procedure)
    • Secondary endpoints: details revised at 3 of 4 entries
    v5
  4. Lead sponsor: [Redacted] to Boston Children's Hospitalv4 Show 5 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: May 2020
    • Study completion date: May 2028
    • Start date: Apr 2016
    • Study title shortened, about 7 words
  5. 2 versions Re-verified since Apr 29, 2016, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
Trial Details
NCT Number NCT02664545
Lead Sponsor Miach Orthopaedics
Conditions
(from sponsor)		 Anterior Cruciate Ligament Tear
Related terms Anterior Cruciate Ligament Injuries
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov