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Bone-Patellar Tendon-Bone Versus Quadriceps Tendon Autograft for Anterior Cruciate Ligament Reconstruction: A Non-Inferiority Trial Regarding Anterior Knee Pain

Study acronym: BTB vs QT
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 8 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 prospective, randomized, single-center, non-inferiority clinical trial will compare anterior knee pain (AKP) after primary anterior cruciate ligament (ACL) reconstruction using either a bone-patellar tendon-bone autograft (BPTB) or a quadriceps tendon autograft with a bone block (BQT). Participants will be randomly assigned in a 1:1 ratio to one of the two graft groups. The primary objective is to determine whether BPTB is non-inferior to BQT with respect to AKP, as assessed by the change in pressure pain threshold from the preoperative measurement to 12 months after surgery. Secondary outcomes will include kneeling pain, the Kujala Anterior Knee Pain Scale, the visual analog scale (VAS) for pain, quadriceps muscle circumference, the subjective International Knee Documentation Committee (IKDC) score, magnetic resonance imaging (MRI) findings, clinical stability, complications, associated surgical procedures, and graft failure.
Trial Details
NCT Number NCT07846709
Lead Sponsor Hospital del Mar
Conditions
(from sponsor)		 Anterior Cruciate Ligament (ACL) Tear
Related terms Lacerations
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov