Active — Not RecruitingNot Applicable

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.

Spain111 participantsStarted 2023-01-07

Plain-language 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 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.

Who can participate

Age range

18 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 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.

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?

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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

ACL Graft-bone integration (CT/MRI)

Timeframe: 12 months

Graft maturation (MRI)

Timeframe: 6-12 months

Trial details

NCT IDNCT07753707

SponsorInstitut Català de Traumatologia i Medicina de l'Esport

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More ACL - Anterior Cruciate Ligament Rupture trials