Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

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

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• infection
• previous surgery experience
• progressive osteoarthritis

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remnant preserving; Anterior cruciate ligament reconstruction: anterior cruciate ligament remnant will be preserved in the operation	Procedure: anterior cruciate ligament reconstruction; Twenty patients planed to undergo anterior cruciate ligament reconstruction by preserving remnant and other twenty patients undergo anterior cruciate ligament reconstruction by preserving remnant.
Active Comparator: Remnant resecting; Anterior cruciate ligament reconstruction: anterior cruciate ligament remnant will be removed in the operation	Procedure: anterior cruciate ligament reconstruction; Twenty patients planed to undergo anterior cruciate ligament reconstruction by preserving remnant and other twenty patients undergo anterior cruciate ligament reconstruction by preserving remnant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location	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.	1 week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Laxity Testing Device(KT1000) for amount of increased anterior knee translation	If increased translation, 3 mm or more will be checked compared to the normal contralateral knee.	6weeks, 3months, 6months and 1years after surgery
Visual Analog Score for pain	Scores range from 0 [no pain] to 10 [worst possible pain].	6weeks, 3months, 6months and 1years after surgery
Lysholm knee score for functional outcome	Scores range from 0 [worst possible function] to 100 [normal function].	6weeks, 3months, 6months and 1years after surgery
International Knee Documentation Committee Score for functional outcome	Scores range from 0 [worst possible function] to 100 [normal function].	6weeks, 3months, 6months and 1years after surgery

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Study Chair: Yong In, MD, PhD, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: August 29, 2015
• First Submitted That Met QC Criteria: September 19, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 19, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: ACL reconstruction