Ireland
--:--IST
Recruiting Not applicable

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

NCT07475351 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-03-23

Condition(s) studied

Anterior Cruciate Ligament (ACL) ReconstructionAnterior Cruciate Ligament Injury

Investigational drug(s) / intervention(s)

Bone-Patellar tendon-BonePatellar tendon-Bone

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Time for injury to surgery of less than six months. * Active athletes (federated or recreational) * Patellar tendon length \> 42mm measured by MRI. * Age between 12 and 40 years old * Genders eligible for Study: both Exclusion Criteria: * Previous surgery or history of ligamentous knee injuries. * Concomitant knee ligament injury * Major meniscal injury (more than 50% of the lateral or medial meniscus) * Chondral injury greater than Outerbridge Grade I-II

Primary outcome measure(s)

  • Donor Site Morbidity — At 3, 8, 12 and 24 months after surgery
    Anterior Cruciate Ligament Donor-site Morbidity Questionnaire will be used to evaluate complications at the harvest site. Scores range from 0 to 100 points, where higher scores indicates better ouctome (absence of donor-site complications).

Trial sites (1)

FacilityCityRegionStatus
Health Sciences Faculty, University of Granada Granada Granada Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07475351 on ClinicalTrials.gov ↗ ← All trials in Spain