Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques

Study Overview
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Brief Summary
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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. 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
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Anterior cruciate ligament (ACL) injury patients : Total 66 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. 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.

Official Title
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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

Conditions
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Rupture of Anterior Cruciate Ligament

Intervention / Treatment
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* Procedure: type of anterior cruciate ligament reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lachman test grade II,III and Pivot shift test grade II,III in physical examination ACL rupture in MRI Age 20 60 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transportal<br>this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique | Procedure: type of anterior cruciate ligament reconstruction<br>* comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation<br>|
| Experimental: Outside in<br>this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique | Procedure: type of anterior cruciate ligament reconstruction<br>* comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascularity of Graft Tendon | 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. | 1yr after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthroscopy Grading | Graft continuity was graded as no tears, superficial tear (fibrillation or tear of superficial fibers), or substantial tear (rupture of 1 or more strands). Graft tension was graded as taut, mild lax, and lax by probing at knee flexion and extension. Synovial coverage of the grafts was graded as excellent (synovial coverage > 80% around graft), fair (coverage > 50%), or poor (coverage < 50%) On the second-look arthroscopic examination, graft continuity, graft tension, graft synovialization, and the presence of cyclops lesions were assessed by a senior surgeon. | 1yr after surgery | 
| Clinical Knee Scoring | Lysholm score (ragne 0-100), HSS (hospital for special surgery) score (0-100) , IKDC (international knee doucomentation commitee) subjective score (0-100), Tegner activity scale (0-10). All of scores demonstrated that higher score means a better outcomes. | 2 yr after surgery | 
| Instability | The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion. | 2 yr after surgery | 
| Graft Maturity (SNQ) |  | 1 yr after surgery |