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

NCT06189573 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Rupture

Interventions

PROCEDURE

Anterior cruciate ligament Reconstruction with autologous quadriceps tendon graft

Surgical reconstruction of anterior cruciate ligament with autologous quadriceps tendon graft

PROCEDURE

Anterior cruciate ligament Reconstruction with autologous bone patellar tendon bone graft

Surgical reconstruction of anterior cruciate ligament with autologous bone patellar tendon bone graft

Sponsors & Collaborators

  • Instituto Nacional de Rehabilitacion

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2027-08-30
Completion
2027-12-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06189573 on ClinicalTrials.gov