Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-40
SponsorUniversidad de Granada
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bone-Patellar tendon-Bone
Procedure/SurgeryAfter 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
Procedure/SurgeryAfter 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Patellar tendon - Bone (PT)Active comparator 1 intervention
Group B: Bone - Patellar tendon - Bone (BPTB)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Donor Site Morbidity
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).
Time frame
At 3, 8, 12 and 24 months after surgerySecondary outcomes
1
Function and activity level
Lysholm-Tegner score will be used to report knee function and activity level. Scores range from 0 to 100 points, where 100 indicates a better outcome (knee function).
Time frame
Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery2
Subjective knee status
International Knee Documentation Committee (IKDC) will be used to assess knee signs and symptoms. Total scores range from 0 to 100 points, where a higher score indicates a better outcome (absence of symptoms and maximum functional level).
Time frame
Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery3
Psychological readiness
Anterior cruciate ligament - Return to Sport after Injury (ACL-RSI) Scale will be used to evaluate psychological readiness of patients to return to sport after ACL reconstruction. Scores range from 0 to 100 points, where a higher score indicates better outcome (full psychological readiness and confidence).
Time frame
Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery4
Joint Awareness
Forgotten Joint Score (FJS) will be used to assessthe patient's ability to forget their affected joint during activities. Scores range from 0 to 100 points, where higher scores indicate a better outcome (patients "forget" the joint, representing a natural feel).
Time frame
Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgerySponsors and contacts
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Source ClinicalTrials.gov