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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.

NCT07753707 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-08-07

No results posted yet for this study

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.

Conditions

  • ACL - Anterior Cruciate Ligament Rupture

Interventions

PROCEDURE

Anterior cruciate ligament (ACL) reconstruction

The three different types of tibial fixation in ACL reconstruction with Hamstring autograft: 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.

Sponsors & Collaborators

  • Institut Català de Traumatologia i Medicina de l'Esport

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2026-01-31
Completion
2026-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753707 on ClinicalTrials.gov