Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques (KR)

Vita Care

Status: Unknown

Conditions: Anterior Cruciate Ligament Injury

Treatments: Procedure: Double bundle anterior cruciate ligament reconstruction; Procedure: Single bundle anterior cruciate ligament reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01358656

KR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Single Bundle Reconstruction

Active Comparator group

Description:

Subjects will undergo single bundle acl reconstruction

Treatment:

Procedure: Single bundle anterior cruciate ligament reconstruction

Double bundle reconstruction

Active Comparator group

Description:

Subjects will undergo double bundle acl reconstruction

Treatment:

Procedure: Double bundle anterior cruciate ligament reconstruction