- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01513434
Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique
January 19, 2012 updated by: Jung Ho Noh, National Police Hospital
The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study.
However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test.
The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
64
Phase
- 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
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Seoul, Korea, Republic of, 138-708
- National Police Hospital
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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
Ages Eligible for Study
17 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- diagnosis of anterior cruciate ligament rupture
Exclusion Criteria:
- female
- over 45 years old
- the subjects who had ACL reconstruction with graft other than Achilles allograft
- the subjects who had concomitant other ligament injuries on the same knee needing surgical treatment
- revision ACL reconstruction
- double bundle ACL reconstruction
- concomitant full thickness cartilage injury needing cartilage repairing surgery
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: transtibial technique
In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.
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Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.
femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw
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Active Comparator: Transportal technique
In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.
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femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw
Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lysholm score
Time Frame: at least two years after surgery
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Lysholm score was superior in transportal technique to transtibial technique.
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at least two years after surgery
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Position of femoral tunnel aperture
Time Frame: within one week after surgery
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The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.
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within one week after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2008
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
January 16, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 20, 2012
Study Record Updates
Last Update Posted (Estimate)
January 20, 2012
Last Update Submitted That Met QC Criteria
January 19, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPH2008-004
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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