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

NCT06189573 | Enrolling By Invitation DMC

• 1 other identifier: Por asignar
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anterior Cruciate Ligament Reconstruction; Bone patellar tendon bone graft; Quadriceps tendon graft; KT-1000; IKDC

Outcome Measures

Primary Outcomes (2)

• International Knee Documentation Committee score (IKDC)

  Minimum value 0 Maximum value 100 Higher scores mean a better outcome Subjective assesment. Three categories are examined by the questionnaire: symptoms, athletic activity, and knee function

  Presurgical, 3, 6, 12 and 24 postsurgical months

• KT-1000

  Device for objective stability measurement.

  Presurgical, 3, 6, 12 and 24 postsurgical months

Secondary Outcomes (4)

• Anterior Knee Pain Scale (Kujala score)

  Presurgical, 3, 6, 12 and 24 postsurgical months

• Lysholm Knee Scoring Scale

  Presurgical, 3, 6, 12 and 24 postsurgical months

• Tegner Activity Scoring Scale

  Presurgical, 3, 6, 12 and 24 postsurgical months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Presurgical, 3, 6, 12 and 24 postsurgical months

Study Arms (2)

Quadriceps Tendon graft

OTHER

Patients with ACL reconstruction with the use of quadriceps tendon graft

Procedure: Anterior cruciate ligament Reconstruction with autologous quadriceps tendon graft

Bone Patellar Tendon Bone Graft

OTHER

Patients with ACL reconstruction with the use of bone patellar tendon bone graft

Procedure: Anterior cruciate ligament Reconstruction with autologous bone patellar tendon bone graft

Interventions

Anterior cruciate ligament Reconstruction with autologous quadriceps tendon graft PROCEDURE

Surgical reconstruction of anterior cruciate ligament with autologous quadriceps tendon graft

Quadriceps Tendon graft

Anterior cruciate ligament Reconstruction with autologous bone patellar tendon bone graft PROCEDURE

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

Bone Patellar Tendon Bone Graft

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Men and women from 15 to 55 years old.
• Primary ACL rupture diagnosed by MRI.
• INR-LGII patients with a complete institutional record.
• Without the presence of systemic, chronic degenerative comorbidities that could affect the quality of the graft. (Diabetes, Thyroid, Autoimmune diseases).

You may not qualify if:

• Grade 2 or 3 posterior cruciate ligament injuries.
• Multiligamentous injuries.
• Severe varus/valgus deformities (mechanical axis outside the range of 35% to 65% of the articular surface of the tibia).
• Previous knee surgeries to be treated.
• Anterior knee pain present (VAS greater than 6), with brush and escape maneuvers positive.
• K\&L osteoarthritis ≥ 2 in the knee to be treated.
• History of intra-articular fractures of the injured knee.
• History of ACL injury and/or surgery in the contralateral knee.
• Previous injury to the patellar or quadriceps tendon (total or partial rupture).
• Symptomatic extensor mechanism tendinopathies.
• High patella (Caton-Deschamps index 1.2 mm)
• ICRS grade III or IV chondral lesion in patella greater than 1cm 2
• Medical conditions that prevent full patient participation (e.g. cancer active, rheumatoid arthritis, etc.)
• Pregnancy.
• Obesity (WCC \>30).

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, 14389, Mexico

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The selection of the graft to be used will be carried out randomly with a box with a closed envelope, which contains the same number of envelopes with one or another type of graft, and the resulting option will be the way in which the type of graft is assigned. graft, which will not be disclosed to the patient during the period of the study. Subjective and objective clinical evaluations with KT-1000 will be carried out preoperatively and postoperatively at 3, 6, 12 and 24 months by 2 evaluators who will be blinded to the type of graft used in each patient, for which the anterior part of his knee will be covered with a 20cm long "micropore" band, so that the type of graft cannot be identified by the evaluator based on the area of the knee and surgical scar.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: Controlled, longitudinal, prospective, randomized, double-blind clinical trial that will include patients from the Luis Guillermo Ibarra-Ibarra National Rehabilitation Institute (INRLGII) of the Sports Orthopedics and Arthroscopy service, with primary ACL injury who undergo surgery with a consistent procedure in ACL reconstruction either with the use of bone tendon bone graft or quadriceps tendon with bone pad in the period from October 2023 to October 2025.

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: January 3, 2024
• Study Start: December 18, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

ME (1)