Effect of Tunnel Placements on Clinical and MRI Findings Two Years After ACL Reconstruction With DB Technique

November 26, 2013 updated by: Tampere University Hospital

Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique

Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee.

Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.

Study Overview

Status

Status

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

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

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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 (Actual)

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.
75

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 Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

Participation Criteria

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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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary ACL reconstruction, closed growth plates

Exclusion Criteria:

  • ligament injury to the opposite knee

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

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.
Other: Double-bundle ACL reconstruction
Procedure: Double-bundle ACL reconstruction
Other: Magnetic resonance imaging (MRI)
MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery.
Device: Magnetic resonance imaging (MRI)
MRI sequences were as follows: sagittal T1-weighted, proton density (PD)-weighted and T2-weighted fast spin echo (FSE) images with 4 mm slice and 1 mm gap, coronal T1-weighted and fat-saturated T2-weighted FSE images with 4 mm slice and 1 mm gap, axial fat saturated PD FSE images with 4 mm slice and 1 mm gap and oblique sagittal and oblique coronal T1 FSE images along AM graft plane with 3 mm slice and 0.3 mm gap.
Other Names:
  • MRI evaluations were made with a 1.5-T Signa Excite HD imager (GE Healthcare, Milwaukee, WI) by use of an eight-channel receiver/transmitter extremity coil.
  • The interpretation of the images was made with the Impax DS 3000 workstation (Agfa HealthCare, Mortsel, Belgium)

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
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages
Time Frame: 2 years after surgery
The measurements of the graft location from the MRI were made by two musculoskeletal radiologists separately and the means of these measurements were used. In brief, first the centers of the tunnels were measured from sagittal images referring to the Blumensaat's line and to the posterior femoral condyle. Then these were divided with the maximum diameters of the femoral condyle parallel to and perpendicular to the Blumensaat's line. In the tibial side, the centers of the tunnels were measured from the anterior edge of the tibial plateau and then divided with the maximum diameter of the plateau, which was measured from the sagittal view.
2 years after surgery
The visibility of the ACL grafts measured from the MRI
Time Frame: 2 years after surgery
Two musculoskeletal radiologists made the interpretation of the images separately and the means of these measurements were used. A graft was considered visible when intact graft fibers were seen. The graft was considered partially visible when only few graft fibers were seen. The graft was considered invisible when no graft fibers were seen.
2 years after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
KT-1000 measurement (mm) of the knees of 61 patients
Time Frame: 2 years after surgery
KT-1000 measurements were reported as millimeters.
2 years after surgery
International Knee Documentation Committee (IKDC) functional score
Time Frame: 2 years after surgery
IKDC functional score was used to evaluate knee functions (IKDC scale: 0-10). Full function without any limitations was scored as 10, while zero indicated that those patients were unable to perform their daily activities.
2 years after surgery
Lysholm knee evaluation score
Time Frame: 2 years after surgery
Patients completed the Lysholm knee score, which measures subjective functions e.g. squatting and running. The scale is 0-100, 100 being perfect functioning of the knee.
2 years after surgery
Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form
Time Frame: 2 years after surgery
The clinical evaluation was performed on the basis of IKDC knee examination form, which gives the final score A-D. A being normal, B nearly normal, C abnormal and D severely abnormal.
2 years after surgery

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.
Tampere University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Timo Järvelä, MD, PhD, Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland

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.
March 1, 2003

Primary Completion (Actual)

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.
September 1, 2010

Study Completion (Actual)

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.
August 1, 2013

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).
October 30, 2013

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.
November 26, 2013

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.
December 4, 2013

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.
December 4, 2013

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.
November 26, 2013

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.
November 1, 2013

More Information

Terms related to this study

Keywords

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.
  • R02071

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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