NCT07475351

Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction

Comparison of Morbidity and Functional Outcomes After Anterior Cruciate Ligament Reconstruction With Bone-Tendon-Bone Graft Versus Patellar Tendon Graft Without Patellar Bone Plug in Competitive Athletes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are: * Does PT graft reduce donor site morbidity compared to the standard BPTB graft? * Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups. Patients will: * Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT) * Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.

Detailed description

Anterior cruciate ligament (ACL) rupture is the most prevalent type of knee ligament injury, representing approximately 50% of all reported knee injuries. This injury has a particularly high impact on most athletes due to the demands of pivoting, jumping and cutting movements required during play. In addition, its consequences include a prolonged recovery period, the risk of reinjury and complications arising from ACL insufficiency, such as knee instability, meniscal tears or osteoarthritis. Given that the primary indicator of successful treatment is the athlete's ability to return to competitive levels, surgical reconstruction of the ACL (ACLR) has become the standard treatment. However, the choice of the optimal graft for ACLR remains controversial. For many authors, bone-patellar tendon-bone (BPTB) graft is considered gold-standard option due to optimal biomechanical properties and low reinjury rate. However, BPTB is usually associated with donor site morbidity, specifically related to kneeling, dysesthesia and anterior knee pain. Given the disadvantages of the BPTB graft, an ACLR based on a bone-patellar tendon graft may be a viable alternative. This technique utilizes an autograft composed of the central third of the patellar tendon and a tibial tubercle bone plug without inclusion of the patellar bone plug, called bone-patellar tendon (BPT). Previous studies have demonstrated lower rates of anterior knee pain in BPT compared to BPTB. However, there is a lack of evidence regarding objective and specific donor site morbidity assessment for both techniques. The main hipothesis of this study is that BPT has similar clinical an functional recovery compared to BPTB with lower rates of anterior knee morbidity.

Conditions

• Anterior Cruciate Ligament (ACL) Reconstruction
• Anterior Cruciate Ligament Injury

Interventions

Type	Name	Description
PROCEDURE	Bone-Patellar tendon-Bone	After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured: * Minimum length: 42mm * Width-based harvesting: if the tendon width is \<30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained. * Bone plugs: patellar and tibial bone plugs (10x20x8mm) are harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \& Coker technique.
PROCEDURE	Patellar tendon-Bone	After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured: * Minimum length: 42mm * Width-based harvesting: if the tendon width is \<30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained. * Bone plugs: a tibial bone plug (10x20x8mm) is harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \& Coker technique.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2026-03-16
• Last updated: 2026-03-23

Locations

1 site across 1 country: Spain