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Clinical Trials/NCT02754674
NCT02754674
Completed
N/A

Comparison of Femoral Tunnel Placement, Geometry and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Technique; Transportal Technique and Outside in Technique With Remnant Preservation. Prospective Randomized Trial

Samsung Medical Center1 site in 1 country67 target enrollmentMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rupture of Anterior Cruciate Ligament
Sponsor
Samsung Medical Center
Enrollment
67
Locations
1
Primary Endpoint
Vascularity of Graft Tendon
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

  1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation.

  2. Subjects: anterior cruciate ligament (ACL) injury 66 patients

    • Double bundle transportal technique with flexible reamer: 33
    • Single bundle outside in technique with remnant preservation: 33

Detailed Description

Anterior cruciate ligament (ACL) injury patients : Total 66 1. Double bundle transportal technique with flexible reamer: 33 * Advantage: more normal ACL reconstruction than single bundle technique * Disadvantage: to make the two bone tunnel must remove all the residual tissue. 2. Single bundle outside in technique with remnant preservation: 33 * Advantage: good for being synovium and revascularization. Remained proprioception function helps to functional recovery. * Disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
December 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Lachman test grade II,III and Pivot shift test grade II,III in physical examination
  • ACL rupture in MRI
  • within 6 months after trauma

Exclusion Criteria

  • osteoarthritis (OA) change in X-ray
  • History of other ligament injury or ACL reconstruction in uninjured knee.
  • operation history of either ipsilateral or contralateral knee(fracture, etc)

Outcomes

Primary Outcomes

Vascularity of Graft Tendon

Time Frame: 1yr after surgery

For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.

Secondary Outcomes

  • Arthroscopy Grading(1yr after surgery)
  • Graft Maturity (SNQ)(1 yr after surgery)
  • Clinical Knee Scoring(2 yr after surgery)
  • Instability(2 yr after surgery)

Study Sites (1)

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