Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques

Not Applicable

• Conditions: Anterior Cruciate Ligament Injury
• Interventions: Procedure: Single bundle anterior cruciate ligament reconstruction; Procedure: Double bundle anterior cruciate ligament reconstruction

• Registration Number: NCT01358656
• Lead Sponsor: Vita Care

Brief Summary

Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20 years. However, data in the literature reveal that approximately 15-25% of patients undergoing surgery still do not present optimal outcomes, which suggests that there is room for improvement of the procedure. A possible explanation for this fact is that most ACL reconstructions consider only one of the functional bundles of the ligament. Our hypothesis is that the ACL reconstruction with the double-bundle technique will be effective in reducing the patients' rotation of the knee joint for high-demanding tasks compared to the patients who had ACL reconstruction with the single-bundle technique.

Detailed Description

The aim of this study is to compare the ACL reconstruction with only one bundle (one tunnel in the tibia and femur) with the procedure to reconstruct the the ACL with two bundles with 2 tunnels in the tibia and 2 in the femur (considered closest to the normal anatomy of of the ACL), both in terms of objective and subjective results.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2011-05
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-23
• Last Update Submitted: 2011-05-23
• Study First Posted: 2011-05-24
• Last Update Posted: 2011-05-24
• Primary Completion: 2011-07
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male or female.
2. Body mass index (BMI), which corresponds to the ratio between weight in kilograms (pounds) and height in m2 (square meters) between 18.5 and 24.99.
3. Anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation.
4. Magnetic resonance imaging (MRI) confirming the ACL injury.
5. Aged between 20 and 45 years.
6. Not having asymmetric varus alignment, greater than or equal to 5 degrees (to eliminate cases with indication for osteotomy of the tibia), using panoramic radiographic comparison of the lower limbs in standing position.
7. Absence of associated ligament instabilities (medial, lateral or posterior).
8. No previous surgery on the affected knee.

Exclusion Criteria

1. New post-surgical trauma after 12 months.
2. Interruption of treatment / follow-up.
3. Postoperative infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Bundle Reconstruction	Single bundle anterior cruciate ligament reconstruction	Subjects will undergo single bundle acl reconstruction
Double bundle reconstruction	Double bundle anterior cruciate ligament reconstruction	Subjects will undergo double bundle acl reconstruction

Primary Outcome Measures

Name	Time	Method
Isokinetic testing	2 years	Tests the muscle power and endurance
Subjective and Objective IKDC Scores	2 years	The subject will answer the subjective IKDC score and the investigator will complete the objective IKDC score
Kinematic evaluation	2 years	The subjects will perform 3 tasks. Walking with no change of direction. Walking with change of direction: walk straight until one foot will touch the force platform and at that moment the subject must change their direction of motion and make a 90° angle with respect to the original trajectory by rotating the body to the side of the foot that will touch the platform. Landing with change of direction: step down 4 steps of a stair as they touch the force platform in the ground, they change the direction of their motion so that the new trajectory will make a 90° angle with the former direction.

Trial Locations

Locations (1)

Instituto Vita; 🇧🇷 São Paulo, Brazil