Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

NCT ID: NCT02555917

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Remnant preserving

Anterior cruciate ligament reconstruction:

anterior cruciate ligament remnant will be preserved in the operation

Group Type EXPERIMENTAL

anterior cruciate ligament reconstruction

Intervention Type 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 resecting

Anterior cruciate ligament reconstruction:

anterior cruciate ligament remnant will be removed in the operation

Group Type ACTIVE_COMPARATOR

anterior cruciate ligament reconstruction

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* infection
* previous surgery experience
* progressive osteoarthritis
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Yong In

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong In, MD, PhD

Role: STUDY_CHAIR

The Catholic University of Korea

Central Contacts

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Yong In, MD, PhD

Role: CONTACT

8290445228

Sung Won Jang, MD

Role: CONTACT

8272333875

Other Identifiers

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ACL reconstruction

Identifier Type: -

Identifier Source: org_study_id

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