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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHospital del Mar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone-Patellar Tendon-Bone Autograft ACL Reconstruction

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Bone-Patellar Tendon-Bone AutograftExperimental treatment 1 intervention
Group B: Quadriceps Tendon AutograftExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pressure Pain Threshold mesured with presure algometry at the center of the Patella

Time frame
Baseline to 12 months after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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