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

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Samsung Medical Center

Status

Completed

Conditions

Rupture of Anterior Cruciate Ligament

Treatments

Procedure: type of anterior cruciate ligament reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT02754674
SMC2013-07-097-001

Details and patient eligibility

About

  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

Full 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.

Enrollment

67 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

67 participants in 2 patient groups

Transportal
Experimental group
Description:
this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique
Treatment:
Procedure: type of anterior cruciate ligament reconstruction
Outside in
Experimental group
Description:
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
Treatment:
Procedure: type of anterior cruciate ligament reconstruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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