Clinical trial NCT02555917: Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction
Official title: Tibia and Femoral Tunnel Location Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* infection
* previous surgery experience
* progressive osteoarthritis

Primary outcomes:
measure: Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Knee Laxity Testing Device(KT1000) for amount of increased anterior knee translation
timeFrame: 6weeks, 3months, 6months and 1years after surgery
measure: Visual Analog Score for pain
timeFrame: 6weeks, 3months, 6months and 1years after surgery
measure: Lysholm knee score for functional outcome
timeFrame: 6weeks, 3months, 6months and 1years after surgery
measure: International Knee Documentation Committee Score for functional outcome
timeFrame: 6weeks, 3months, 6months and 1years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of Korea
name: Yong In, MD, PhD
role: STUDY_CHAIR
References: