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Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv12
  2. Primary completion date: Mar 2025 to Dec 2026v11
  3. 3 versions Re-verified since Feb 18, 2022, no change to tracked fieldsv8-v10
  4. Primary completion date: Oct 2021 to Mar 2025
    • Study completion date: Oct 2027 to Mar 2033
    v7
  5. 2 versions Re-verified since Dec 3, 2019, no change to tracked fieldsv5-v6
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Oct 2027 to Oct 2021v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method. The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.
Trial Details
NCT Number NCT02918734
Lead Sponsor St. Olavs Hospital
Collaborators: Rosenborgklinikken
Conditions
(from sponsor)		 Knee Injuries
Related terms Knee Injuries
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov