Reconstruction of the ACL With QT Graft With Bone Plug vs BPTB (NCT06189573) | Clinical Trial Compass
By InvitationNot Applicable
Reconstruction of the ACL With QT Graft With Bone Plug vs BPTB
Mexico80 participantsStarted 2023-12-18
Plain-language 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.
Who can participate
Age range
15 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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).
Perioperative elimination criteria:
* Medial or lateral meniscus injury \>50% non-repairable.
* Medial and/or lateral menisectomy \> 50%
* Grade 2-3 ligament instability associated with ACL injury.
* Cartilage lesion \>2 cm2 ICRS grade 3-4, untreate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Knee Documentation Committee score (IKDC)
Timeframe: Presurgical, 3, 6, 12 and 24 postsurgical months
2
KT-1000
Timeframe: Presurgical, 3, 6, 12 and 24 postsurgical months