Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques (KR)
|ClinicalTrials.gov Identifier: NCT01358656|
Recruitment Status : Unknown
Verified May 2011 by Vita Care.
Recruitment status was: Recruiting
First Posted : May 24, 2011
Last Update Posted : May 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injury||Procedure: Single bundle anterior cruciate ligament reconstruction Procedure: Double bundle anterior cruciate ligament reconstruction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of the Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques: Prospective Clinical Study|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||January 2012|
Active Comparator: Single Bundle Reconstruction
Subjects will undergo single bundle acl reconstruction
Procedure: Single bundle anterior cruciate ligament reconstruction
The surgical technique includes ACL reconstruction with graft of two autologous tendons - the semitendinous and gracilis - fixed in one tibial tunnel and one femoral tunnel. Once the graft is obtained, the arthroscopy-assisted ACL reconstruction is performed using anterolateral, anteromedial and accessory anteromedial portals. The first tunnel to be built is femoral tunnel, through a Smith & Nephew femoral guide inserted into the anteromedial portal in the 10:30 h position for the right knee and 1:30 h position for the left knee, with the knee at 120° of flexion. The next tunnel is tibial tunnel. The tunnel has its point of entry anterior to the fibers of the superficial medial collateral ligament, and the tibial guide must be adjusted at 45 degrees. The new ligament is fixed onto the tibia and femur with a biodegradable interference screw.
Active Comparator: Double bundle reconstruction
Subjects will undergo double bundle acl reconstruction
Procedure: Double bundle anterior cruciate ligament reconstruction
The ACL reconstruction is performed with graft of two autologous tendons -the semitendinous and gracilis- fixed in two tibial tunnels and two femoral tunnels. The first tunnel to be built is the anteromedial (AM) femoral tunnel, through femoral guide inserted into the AM portal in the 10:30 h position for the right knee and 1:30 h position for the left knee, with the knee at 120° of flexion. Then we drill the PL femoral tunnel in its anatomical position from the accessory AM portal, with the knee at 120° of flexion. The next tunnels are the PM and AM tunnels. The PL tunnel has its point of entry anterior to the fibers of the superficial medial collateral ligament, and the tibial guide must be adjusted at 45º. The AM tunnel has its point of entry more lateral, and a bone bridge of at least one cm must be left between the tunnels, and the tibial guide adjusted at 55º. Both bundles must be fixed onto the tibia and femur with a biodegradable interference screw.
- Isokinetic testing [ Time Frame: 2 years ]Tests the muscle power and endurance
- Subjective and Objective IKDC Scores [ Time Frame: 2 years ]The subject will answer the subjective IKDC score and the investigator will complete the objective IKDC score
- Kinematic evaluation [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358656
|Contact: Caio O D'Elia, MScfirstname.lastname@example.org|
|Contact: Isabela U Luques, MScemail@example.com|
|São Paulo, Brazil, 01239040|
|Contact: Isabela U Luques, MSc 551131238470 firstname.lastname@example.org|