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NCT Number: NCT02754674

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

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

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

type of anterior cruciate ligament reconstruction

Procedure

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

Primary outcomes

  1. 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

  1. Arthroscopy Grading

    Time frame: 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.

  2. Clinical Knee Scoring

    Time frame: 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.

  3. Instability

    Time frame: 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.

  4. Graft Maturity (SNQ)

    Time frame: 1 yr after surgery

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Apr 28, 2016
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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