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The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Jan 31, 2026 to Feb 28, 2026v21
  2. Primary completion date: Jun 30, 2025 to Jan 31, 2026v20
  3. Primary completion date: Apr 17, 2024 to Jun 30, 2025v19
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 11
    v18
  5. Primary completion date: Apr 17, 2022 to Apr 17, 2024
    • Study completion date: Apr 17, 2032 to Apr 17, 2034
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 6 to 7v16
  2. Study sites: 4 to 6v15
  3. Site contacts updated at 1 of 4 sitesv14
  4. Study sites: 3 to 4v13
  5. Trial status: Active, Not Recruiting to Recruitingv12 Show 4 more changesShow less
    • Study sites: 2 to 3
    • Interventions: Bridge-Enhanced ACL Repair (BEAR) (Device) to Bridge-Enhanced ACL Restoration (BEAR) (Device)
    • Study description revised
    • Study title revised
  6. Lead sponsor: Boston Children's Hospital to Miach Orthopaedics
    • Study description shortened, about 16 words
    • Collaborators shortened, about 3 words
    v11
  7. Re-verified, no change to tracked fieldsv10
  8. Enrollment target: 300 to 250
    • Study description shortened, about 3 words
    v9
  9. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v8
  10. Lead sponsor: [Redacted] to Boston Children's Hospitalv7 Show 6 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Apr 17, 2022
    • Study completion date: Apr 17, 2032
    • Start date: Apr 17, 2018
    • Collaborators expanded, about 3 words
    • Study title shortened, about 2 words
  11. 5 versions Re-verified since Dec 15, 2017, no change to tracked fieldsv2-v6
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Trial Details
NCT Number NCT03348995
Lead Sponsor Miach Orthopaedics
Conditions
(from sponsor)		 Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
Related terms Anterior Cruciate Ligament Injuries
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov