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.

Running, not enrolling · Not applicable

Conditions studied: ACL - Anterior Cruciate Ligament Rupture

In brief

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 four tibial fixation techniques is superior in terms of: Graft-bone integration (CT/MRI), Graft maturation (MRI), Clinical outcomes (IKDC, Lysholm, Tegner scores; manual and instrumented knee stability with KT-1000 arthrometer). Secondary Objectives Compare clinical outcomes among groups (IKDC, Lysholm, Tegner). Compare re-rupture rates and patient satisfaction. Study Design Prospective randomized trial. The study will be registered in the international Clinical Trials registry. Inclusion Criteria Age ≥18 years. Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons. Exclusion Criteria Age ≥55 years. Patients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts. Malpositioned tunnels (evaluated by MRI at 6 months postop). Previous knee surgery. Femoral or tibial deformities. Multiligament injuries. Note: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria. Randomization Patients meeting inclusion/exclusion criteria will be randomized (via 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, one mm larger than the tunnel diameter. Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button/plate. Sample size: 37 patients per group, 111 total. Follow-up Radiographic, CT, and MRI evaluation pre-op, at 15 days, and at 1 year post-op. Clinical and radiological follow-up for 1 year. Statistical Analysis In the prospective phase, Student's t-test will be performed for comparison of pre- and postoperative variables. All variables will also be compared between groups and within groups (baseline vs. end of follow-up) using analysis of variance (ANOVA). Linear regression models will be applied to test for potential significance that could be masked by confounding factors.

Key facts

Study ID
NCT07753707
Run by
Institut Català de Traumatologia i Medicina de l'Esport
People needed
111
Starts
2023-01-07
Expected to finish
2026-12-30
Last updated by the study team
2026-08-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.