Skip to main content
Clinical Trials/NCT02555917
NCT02555917
Unknown
N/A

Tibia and Femoral Tunnel Location Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

The Catholic University of Korea0 sites40 target enrollmentSeptember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Rupture
Sponsor
The Catholic University of Korea
Enrollment
40
Primary Endpoint
Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location
Last Updated
10 years ago

Overview

Brief Summary

Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and it gives excellent results. For leading to successful result of anterior cruciate ligament reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. If selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of transplanted tendon, loss of range of motion, instability, failure of transplantation and risk of arthritis. It is known that selection of inappropriate tibial tunnel location is the most common cause of anterior cruciate ligament reconstruction failure.

Recently many studies reconstructed at anatomical lesion instead of isometric point. And some cadaver studies reported that tibial insertion of anterior cruciate ligament has "C" shape. There are two methods for anterior cruciate ligament reconstruction. One is preserving remnant and the other is removing remnant.

This study aims to compare the tibia and femoral tunnel location of remnant preserving and remnant resecting anterior cruciate ligament reconstruction.

Detailed Description

The study design is a double-blind randomized controlled trial. Randomly, twenty patients planed to undergo anterior cruciate ligament reconstruction using autograft by remnant preserving and other twenty patients undergo anterior cruciate ligament reconstruction using autograft by resecting anterior cruciate ligament. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Visual Analog Score, lachman test, anterior laxity, Lysholm knee score, international knee documentation committee score. Femoral and tibial tunnel location will be analyzed by three-dimensional computed tomography using Bernard quadrant method after surgery. The present study aimed to determine and compare (1) the accuracy of tibia and femoral tunnel location and (2) postoperative functional outcome after anterior cruciate ligament reconstruction between remnant preserving group versus remnant resecting group.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
September 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yong In

Professor

The Catholic University of Korea

Eligibility Criteria

Inclusion Criteria

  • over 19 years old
  • patients for ACL reconstruction having medicare insurance

Exclusion Criteria

  • infection
  • previous surgery experience
  • progressive osteoarthritis

Outcomes

Primary Outcomes

Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location

Time Frame: 1 week after surgery

The locations of the tunnels will be quantified and presented as the percentage distance from the deepest subchondral contour and the intercondylar notch roof to the center of the tunnel by use of the Bernard quadrant method.

Secondary Outcomes

  • Visual Analog Score for pain(6weeks, 3months, 6months and 1years after surgery)
  • Knee Laxity Testing Device(KT1000) for amount of increased anterior knee translation(6weeks, 3months, 6months and 1years after surgery)
  • Lysholm knee score for functional outcome(6weeks, 3months, 6months and 1years after surgery)
  • International Knee Documentation Committee Score for functional outcome(6weeks, 3months, 6months and 1years after surgery)

Similar Trials