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

NCT07846709 | Not Yet Recruiting

• 1 other identifier: 2026/12770/I
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, prospective, single-center, non-inferiority clinical trial will compare anterior knee pain after primary anterior cruciate ligament (ACL) reconstruction using either a bone-patellar tendon-bone autograft or a quadriceps tendon autograft with a bone block. Participants will be randomly assigned in a 1:1 ratio to one of the two graft groups. The primary objective is to determine whether bone-patellar tendon-bone autograft is non-inferior to quadriceps tendon autograft regarding anterior knee pain, assessed by the change in pressure pain threshold from the preoperative measurement to 12 months after surgery. Secondary outcomes will include kneeling pain, Kujala Anterior Knee Pain Scale, visual analog scale for pain, quadriceps muscle circumference, subjective IKDC score, magnetic resonance imaging findings, clinical stability, complications, associated surgical procedures, and graft failure.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Keywords

Anterior cruciate ligament reconstruction; Bone-patellar tendon-bone autograft; Quadriceps tendon autograft; Anterior knee pain; Pressure algometry; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 12 months after surgery

Study Arms (2)

Bone-Patellar Tendon-Bone Autograft

EXPERIMENTAL

Bone-Patellar Tendon-Bone Autograft arm Participants will undergo primary anterior cruciate ligament reconstruction using a bone-patellar tendon-bone autograft harvested from the patellar tendon, with bone blocks approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be implanted using the standardized arthroscopic ACL reconstruction technique used at the study center

Procedure: Bone-Patellar Tendon-Bone Autograft ACL Reconstruction

Quadriceps Tendon Autograft

EXPERIMENTAL

Quadriceps Tendon Autograft arm Participants will undergo primary anterior cruciate ligament reconstruction using a quadriceps tendon autograft with a bone block approximately 9-10 mm in diameter and 10-20 mm in length. The tendon will be harvested as a partial-thickness graft using a standardized technique and implanted using the same standardized arthroscopic ACL reconstruction principles.

Procedure: Quadriceps Tendon Autograft ACL Reconstruction

Interventions

Bone-Patellar Tendon-Bone Autograft ACL Reconstruction PROCEDURE

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

Bone-Patellar Tendon-Bone Autograft

Quadriceps Tendon Autograft ACL Reconstruction PROCEDURE

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.

Quadriceps Tendon Autograft

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical and/or radiological diagnosis of an anterior cruciate ligament (ACL) injury with an indication for primary surgical reconstruction.
• Ability to understand the study information and provide written informed consent.
• Willingness to participate in the study and complete the planned clinical and radiological follow-up.
• Technical feasibility of performing either a bone-patellar tendon-bone (BPTB) autograft or a quadriceps tendon autograft, as assessed by the treating surgeon.

You may not qualify if:

• Previous surgery on the affected knee.
• Previous fracture of the proximal tibia, distal femur, or patella in the affected knee.
• Clinical history of patellofemoral pain syndrome, symptomatic insertional patellar tendinopathy, or symptomatic insertional quadriceps tendinopathy.
• Need to harvest a graft that does not meet the predefined study standards.
• Pain-amplifying condition or generalized chronic pain that could interfere with the assessment of anterior knee pain.
• Psychiatric, cognitive, or mental disorders that may impair follow-up, understanding of the study, or valid completion of questionnaires.
• Medical contraindication to surgery or magnetic resonance imaging.
• Refusal to participate or withdrawal of informed consent.

Sponsors & Collaborators

• Hospital del Mar: lead

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopedic surgeon

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09