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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Vita Care.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vita Care
ClinicalTrials.gov Identifier:
NCT01358656
First received: May 19, 2011
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament Injury
Procedure: Single bundle anterior cruciate ligament reconstruction
Procedure: Double bundle anterior cruciate ligament reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques: Prospective Clinical Study

Resource links provided by NLM:


Further study details as provided by Vita Care:

Primary Outcome Measures:
  • Isokinetic testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Tests the muscle power and endurance

  • Subjective and Objective IKDC Scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The subject will answer the subjective IKDC score and the investigator will complete the objective IKDC score

  • Kinematic evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358656

Contacts
Contact: Caio O D'Elia, MSc 551131238482 caio@vita.org.br
Contact: Isabela U Luques, MSc 551131238470 isabela@vita.org.br

Locations
Brazil
Instituto Vita Recruiting
São Paulo, Brazil, 01239040
Contact: Isabela U Luques, MSc    551131238470    isabela@vita.org.br   
Sponsors and Collaborators
Vita Care
  More Information

No publications provided

Responsible Party: Vita Care
ClinicalTrials.gov Identifier: NCT01358656     History of Changes
Other Study ID Numbers: KR
Study First Received: May 19, 2011
Last Updated: May 23, 2011
Health Authority: Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on November 27, 2014