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

Primary Purpose

Anterior Cruciate Ligament Injury

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Single bundle anterior cruciate ligament reconstruction

Double bundle anterior cruciate ligament reconstruction

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female.
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.
Anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation.
Magnetic resonance imaging (MRI) confirming the ACL injury.
Aged between 20 and 45 years.
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.
Absence of associated ligament instabilities (medial, lateral or posterior).
No previous surgery on the affected knee.

Exclusion Criteria:

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

Sites / Locations

Instituto VitaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Single Bundle Reconstruction

Double bundle reconstruction

Arm Description

Subjects will undergo single bundle acl reconstruction

Subjects will undergo double bundle acl reconstruction

Outcomes

Primary Outcome Measures

Isokinetic testing

Tests the muscle power and endurance

Subjective and Objective IKDC Scores

The subject will answer the subjective IKDC score and the investigator will complete the objective IKDC score

Kinematic evaluation

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01358656

First Posted

May 19, 2011

Last Updated

May 23, 2011

Sponsor

Vita Care

1. Study Identification

Unique Protocol Identification Number

NCT01358656

Brief Title

Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques

Acronym

Official Title

Comparison of the Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques: Prospective Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

July 2011 (Anticipated)

Study Completion Date

January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Vita Care

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Bundle Reconstruction

Arm Type

Active Comparator

Arm Description

Subjects will undergo single bundle acl reconstruction

Arm Title

Double bundle reconstruction

Arm Type

Active Comparator

Arm Description

Subjects will undergo double bundle acl reconstruction

Intervention Type

Procedure

Intervention Name(s)

Single bundle anterior cruciate ligament reconstruction

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Double bundle anterior cruciate ligament reconstruction

Intervention Description

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.

Primary Outcome Measure Information:

Title

Isokinetic testing

Description

Tests the muscle power and endurance

Time Frame

2 years

Title

Subjective and Objective IKDC Scores

Description

The subject will answer the subjective IKDC score and the investigator will complete the objective IKDC score

Time Frame

2 years

Title

Kinematic evaluation

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female. 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. Anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation. Magnetic resonance imaging (MRI) confirming the ACL injury. Aged between 20 and 45 years. 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. Absence of associated ligament instabilities (medial, lateral or posterior). No previous surgery on the affected knee. Exclusion Criteria: New post-surgical trauma after 12 months. Interruption of treatment / follow-up. Postoperative infection.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caio O D'Elia, MSc

Phone

551131238482

caio@vita.org.br

First Name & Middle Initial & Last Name or Official Title & Degree

Isabela U Luques, MSc

Phone

551131238470

isabela@vita.org.br

Facility Information:

Facility Name

Instituto Vita

City

São Paulo

ZIP/Postal Code

01239040

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabela U Luques, MSc

Phone

551131238470

isabela@vita.org.br

12. IPD Sharing Statement

Learn more about this trial

Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques

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