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

May 23, 2011 updated by: Vita Care

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01239040
        • Recruiting
        • Instituto Vita
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isokinetic testing
Time Frame: 2 years
Tests the muscle power and endurance
2 years
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
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vita Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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