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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07753707

Enrollment

111

Registered

2026-08-07

Start date

2023-01-07

Completion date

2026-12-30

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL - Anterior Cruciate Ligament Rupture

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.

Interventions

PROCEDUREAnterior 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ACL Graft-bone integration (CT/MRI)	12 months	Graft-bone integration assessed by CT or MRI according to tunnel healing and bone incorporation.
Graft maturation (MRI)	6-12 months	Graft maturation assessed on MRI using the Signal-to-Noise Quotient (SNQ).

Secondary

Measure	Time frame	Description
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score	12 months	Patient-reported knee function. Scores range from 0 to 100, with higher scores indicating better knee function.
Tegner Activity Scale	12 months	Activity level assessed using the Tegner Activity Scale. Scores range from 0 to 10, with higher scores indicating higher activity levels.
Side-to-side anterior knee laxity measured with KT-1000 arthrometer	12 months	Anterior tibial translation measured using a KT-1000 arthrometer. Lower side-to-side differences indicate better knee stability.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026