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Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transtibial technique
Transportal technique
anterior cruciate ligament reconstruction
Sponsored by
National Police Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture

Eligibility Criteria

17 Years - 45 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Police Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

transtibial technique

Transportal technique

Arm Description

In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.

In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.

Outcomes

Primary Outcome Measures

Lysholm score
Lysholm score was superior in transportal technique to transtibial technique.
Position of femoral tunnel aperture
The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2012
Last Updated
January 19, 2012
Sponsor
National Police Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01513434
Brief Title
Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Police Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transtibial technique
Arm Type
Active Comparator
Arm Description
In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.
Arm Title
Transportal technique
Arm Type
Active Comparator
Arm Description
In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.
Intervention Type
Procedure
Intervention Name(s)
transtibial technique
Intervention Description
Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.
Intervention Type
Procedure
Intervention Name(s)
Transportal technique
Other Intervention Name(s)
anteromedial portal technique
Intervention Description
Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.
Intervention Type
Procedure
Intervention Name(s)
anterior cruciate ligament reconstruction
Intervention Description
femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw
Primary Outcome Measure Information:
Title
Lysholm score
Description
Lysholm score was superior in transportal technique to transtibial technique.
Time Frame
at least two years after surgery
Title
Position of femoral tunnel aperture
Description
The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.
Time Frame
within one week after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Police Hospital
City
Seoul
ZIP/Postal Code
138-708
Country
Korea, Republic of

12. IPD Sharing Statement

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Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique

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