Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

NCT02555917 | Unknown

• 1 other identifier: ACL reconstruction
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Knee Laxity Testing Device(KT1000) for amount of increased anterior knee translation

  6weeks, 3months, 6months and 1years after surgery

• Visual Analog Score for pain

  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

Study Arms (2)

Remnant preserving

EXPERIMENTAL

Anterior cruciate ligament reconstruction: anterior cruciate ligament remnant will be preserved in the operation

Procedure: anterior cruciate ligament reconstruction

Remnant resecting

ACTIVE COMPARATOR

Anterior cruciate ligament reconstruction: anterior cruciate ligament remnant will be removed in the operation

Procedure: anterior cruciate ligament reconstruction

Interventions

anterior cruciate ligament reconstruction PROCEDURE

Twenty patients planed to undergo anterior cruciate ligament reconstruction by preserving remnant and other twenty patients undergo anterior cruciate ligament reconstruction by preserving remnant.

Remnant preserving; Remnant resecting

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• infection
• previous surgery experience
• progressive osteoarthritis

Sponsors & Collaborators

• The Catholic University of Korea: lead

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Yong In, MD, PhD

  The Catholic University of Korea

  STUDY CHAIR

Central Study Contacts

Yong In, MD, PhD

CONTACT

8290445228; iy1000@catholic.ac.kr

Sung Won Jang, MD

CONTACT

8272333875; garetme@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 22, 2015

Record last verified: 2015-09