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

Samsung Medical Center67 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rupture of Anterior Cruciate Ligament

Interventions

type of anterior cruciate ligament reconstructionPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 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)

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 1yr after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 yr after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.