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NCT07753707
Influence of the Different Types of Tibial Fixation in the Reconstruction of the Anterior Cruciate Ligament of the Knee: Osseous Integration, Ligament Maturation and Clinical Results.
Conditions: ACL - Anterior Cruciate Ligament Rupture
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 111
Sponsor: Institut Català de Traumatologia i Medicina de l'Esport
Location: Hospital Universitario Dexeus Barcelona BARCELONA
Summary
Influence of different tibial fixation methods in anterior cruciate ligament (ACL) reconstruction: bone integration, graft maturation, and clinical outcomes.
Primary Objective
To assess whether any of the three tibial fixation techniques is superior in terms of:
* Graft-bone integration (CT/MRI).
* Graft maturation (MRI, signal-to-noise quotient at 12 months).
* Clinical outcomes (IKDC, Lysholm and Tegner scores; manual and instrumented knee stability with the Lachman and pivot-shift tests and the KT-1000 arthrometer).
Secondary Objectives
* Compare clinical outcomes among groups (IKDC, Lysholm, Tegner).
* Compare complication and re-rupture rates and patient satisfaction among groups.
Study Design Prospective, single-center, three-arm randomized controlled trial.
Inclusion Criteria
* Age 18 to 50 years.
* Primary complete ACL tear with indication for arthroscopic reconstruction with hamstring autograft.
Exclusion Criteria
* Revision ACL surgery.
* Use of a graft other than hamstring tendons.
* Kellgren-Lawrence grade III-IV osteoarthritis.
* Inflammatory knee disease. Note: soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.
Randomization
Patients meeting the inclusion and exclusion criteria are randomized (Research Randomizer, https://www.randomizer.org/) into 3 groups:
* Group A (TORN): bioabsorbable interference screw, same diameter as the tunnel.
* Group B (TORN+1): bioabsorbable interference screw, 1 mm larger than the tunnel diameter.
* Group C (TORN-BT): interference screw (same diameter as the tunnel) plus second fixation with a cortical button.
Sample size: 37 patients per group, 111 in total.
Follow-up
* Preoperative radiographic evaluation.
* CT at 15 days and at 12 months postoperatively.
* MRI at 12 months postoperatively.
* Clinical follow-up at 2 years postoperatively.
Statistical Analysis Pre- and postoperative variables will be compared within groups, and all variables will be compared between groups using parametric or non-parametric tests according to data distribution (Student's t-test or ANOVA, or their non-parametric equivalents). Linear regression models will be applied to test for potential significance that could be masked by confounding factors.
Eligibility Criteria
Inclusion Criteria
* Age 18 to 50 years.
* Primary complete ACL tear with indication for arthroscopic reconstruction with hamstring autograft.
Exclusion Criteria
* Revision ACL surgery.
* Use of a graft other than hamstring tendons.
* Kellgren-Lawrence grade III-IV osteoarthritis.
* Inflammatory knee disease. Note: soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.
Source: ClinicalTrials.gov (NCT07753707). StuddyBuddy aggregates publicly available trial information.