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Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques

NCT ID: NCT02754674

Last Updated: 2019-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-12-31

Brief Summary

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1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation.
2. Subjects: anterior cruciate ligament (ACL) injury 66 patients

* Double bundle transportal technique with flexible reamer: 33
* Single bundle outside in technique with remnant preservation: 33

Detailed Description

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Anterior cruciate ligament (ACL) injury patients : Total 66

1. Double bundle transportal technique with flexible reamer: 33

* Advantage: more normal ACL reconstruction than single bundle technique
* Disadvantage: to make the two bone tunnel must remove all the residual tissue.
2. Single bundle outside in technique with remnant preservation: 33

* Advantage: good for being synovium and revascularization. Remained proprioception function helps to functional recovery.
* Disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.

Conditions

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Rupture of Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transportal

this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique

Group Type EXPERIMENTAL

type of anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation

Outside in

this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique

Group Type EXPERIMENTAL

type of anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation

Interventions

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type of anterior cruciate ligament reconstruction

comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Lachman test grade II,III and Pivot shift test grade II,III in physical examination
2. ACL rupture in MRI
3. Age 20\~60
4. within 6 months after trauma

Exclusion Criteria

1. osteoarthritis (OA) change in X-ray
2. History of other ligament injury or ACL reconstruction in uninjured knee.
3. operation history of either ipsilateral or contralateral knee(fracture, etc)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joon Ho Wang, MD, Ph D

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Wang JH, Lee ES, Lee BH. Paradoxical tunnel enlargement after ACL reconstruction with hamstring autografts when using beta-TCP containing interference screws for tibial aperture fixation- prospectively comparative study. BMC Musculoskelet Disord. 2017 Sep 16;18(1):398. doi: 10.1186/s12891-017-1757-0.

Reference Type DERIVED
PMID: 28915914 (View on PubMed)

Other Identifiers

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SMC2013-07-097-001

Identifier Type: -

Identifier Source: org_study_id