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

Not Applicable
Completed
Conditions
Rupture of Anterior Cruciate Ligament
Interventions
Procedure: type of anterior cruciate ligament reconstruction
Registration Number
NCT02754674
Lead Sponsor
Samsung Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
67
Inclusion Criteria
  1. Lachman test grade II,III and Pivot shift test grade II,III in physical examination
  2. ACL rupture in MRI
  3. Age 20~60
  4. within 6 months after trauma
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Exclusion Criteria
  1. osteoarthritis (OA) change in X-ray
  2. History of other ligament injury or ACL reconstruction in uninjured knee.
  3. operation history of either ipsilateral or contralateral knee(fracture, etc)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Transportaltype of anterior cruciate ligament reconstructionthis is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique
Outside intype of anterior cruciate ligament reconstructionthis is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique
Primary Outcome Measures
NameTimeMethod
Vascularity of Graft Tendon1yr 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 Outcome Measures
NameTimeMethod
Arthroscopy Grading1yr after surgery

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.

Graft Maturity (SNQ)1 yr after surgery
Clinical Knee Scoring2 yr after surgery

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.

Instability2 yr after surgery

The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

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