Clinical Trial

Reconstruction of the ACL With QT Graft With Bone Plug vs BPTB

Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
Background: Anterior cruciate ligament (ACL) injury is one of the most common orthopedic injuries worldwide. Currently, the use of the bone patellar tendon bone graft (BPTB) technique is considered the gold standard. The use of the quadriceps tendon graft (QT) has gained greater interest in recent years, this because with an adequate technique it is possible to obtain a biomechanically superior graft with fewer adverse events. The objective of this study is to compare the objective and subjective clinical results, as well as the presence or not of adverse events in ACL reconstruction with these 2 types of grafts in the medium term. Materials and methods: Controlled, longitudinal, prospective, randomized, double-blind clinical trial that will include patients of both sexes, between 15 and 55 years of age, with primary ACL injury who attend the outpatient clinic of the Sports Orthopedics Service. INRLGII arthroscopy between October 2023 and October 2025, prior informed consent. Graft selection will be done randomly 1:1 between bone-tendon-bone (BPTB) graft Vs. quadriceps tendon graft (QT) for ACL reconstruction surgery. The clinical evaluation of the patients Will be done by 2 blinded evaluators, through the objective measurement of KT-1000 and the use of subjective clinical knee scales, both preoperatively and at 3-6-12 and 24 months. The presence or absence of adverse events or complications will be documented during a minimum of 2 years of follow-up. Parametric and non-parametric statistical tests will be used depending on whether the distribution is normal or not, for dependent and independent groups, using the SPSS version 25 statistical program.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-12-18; most recent amendment 2025-05-23.
Status change: Recruiting → Enrolling by Invitation 2025-05-23
Status change: Not Yet Recruiting → Recruiting 2024-01-30
Trial Details
NCT Number NCT06189573
Lead Sponsor Instituto Nacional de Rehabilitacion
Conditions Anterior Cruciate Ligament Rupture
Enrollment 80 participants
Start Date 2023-12-18
Primary Completion 2027-08-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-30