Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02555917
• Other study ID #: ACL reconstruction
• Status: Not yet recruiting
• Phase: N/A
• First received: August 29, 2015
• Last updated: September 19, 2015
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2015
• Source: The Catholic University of Korea
• Contact: Yong In, MD, PhD
• Phone: 8290445228
• Email: iy1000[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• over 19 years old

• patients for ACL reconstruction having medicare insurance

Exclusion Criteria:

• infection

• previous surgery experience

• progressive osteoarthritis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Visual Analog Score for pain	Scores range from 0 [no pain] to 10 [worst possible pain].	6weeks, 3months, 6months and 1years after surgery	No
Secondary	Lysholm knee score for functional outcome	Scores range from 0 [worst possible function] to 100 [normal function].	6weeks, 3months, 6months and 1years after surgery	No
Secondary	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	No