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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
Sponsor: Hospital del Mar
Summary
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.
Official title: Randomized Non-inferiority Clinical Trial Comparing Anterior Knee Pain After Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Autograft Versus Quadriceps Tendon Autograft
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-10-05
Completion Date
2029-10
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Bone-Patellar Tendon-Bone Autograft ACL Reconstruction
BPTB Autograft ACL Reconstruction Primary ACL reconstruction using an autologous bone-patellar tendon-bone graft harvested from the central patellar tendon, with bone blocks approximately 9-10 mm in diameter and 10-20 mm in length. Graft harvest and reconstruction will be performed using a standardized arthroscopic technique
Quadriceps Tendon Autograft ACL Reconstruction
Quadriceps Tendon Autograft ACL Reconstruction Primary ACL reconstruction using an autologous quadriceps tendon graft with a bone block approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be harvested as a partial-thickness quadriceps tendon graft using a standardized technique and implanted arthroscopically.