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 | Active Not Recruiting DMC

• 1 other identifier: LCA-INT-22
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• ACL Graft-bone integration (CT/MRI)

  Graft-bone integration assessed by CT or MRI according to tunnel healing and bone incorporation.

  12 months

• Graft maturation (MRI)

  Graft maturation assessed on MRI using the Signal-to-Noise Quotient (SNQ).

  6-12 months

Secondary Outcomes (3)

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score

  12 months

• Tegner Activity Scale

  12 months

• Side-to-side anterior knee laxity measured with KT-1000 arthrometer

  12 months

Study Arms (3)

Group A (TORN): tibial graft fixation bioabsorbable interference screw, same diameter as the tunnel.

ACTIVE COMPARATOR

Procedure: Anterior cruciate ligament (ACL) reconstruction

Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.

ACTIVE COMPARATOR

Procedure: Anterior cruciate ligament (ACL) reconstruction

Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button

ACTIVE COMPARATOR

Procedure: Anterior cruciate ligament (ACL) reconstruction

Interventions

Anterior cruciate ligament (ACL) reconstruction PROCEDURE

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.

Group A (TORN): tibial graft fixation 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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years.
• Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català de Traumatologia i Medicina de l'Esport: lead

Study Sites (1)

Hospital Universitario Dexeus

Barcelona, BARCELONA, 08028, Spain

Location

Related Publications (2)

• Mathew M, Dhollander A, Getgood A. Anterolateral Ligament Reconstruction or Extra-Articular Tenodesis: Why and When? Clin Sports Med. 2018 Jan;37(1):75-86. doi: 10.1016/j.csm.2017.07.011. Epub 2017 Oct 3.

  PMID: 29173559 BACKGROUND

• Granan LP, Bahr R, Steindal K, Furnes O, Engebretsen L. Development of a national cruciate ligament surgery registry: the Norwegian National Knee Ligament Registry. Am J Sports Med. 2008 Feb;36(2):308-15. doi: 10.1177/0363546507308939. Epub 2007 Nov 7.

  PMID: 17989167 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: August 7, 2026
• Study Start: January 7, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

ES (1)