Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques
- 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
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transportal type of anterior cruciate ligament reconstruction this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique Outside in type of anterior cruciate ligament reconstruction 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
- Primary Outcome Measures
Name Time Method Vascularity of Graft Tendon 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 Outcome Measures
Name Time Method Arthroscopy Grading 1yr 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 Scoring 2 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.Instability 2 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