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Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction

NCT ID: NCT02633410

Last Updated: 2015-12-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2015-07-31

Brief Summary

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The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Detailed Description

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The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Conditions

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Anterior Cruciate Ligament Reconstruction

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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Transtibial

Transtibial technique used to create femoral tunnel

Group Type ACTIVE_COMPARATOR

Femoral tunnel creation

Intervention Type PROCEDURE

Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned

Anteromedial

Anteromedial technique used to create femoral tunnel

Group Type ACTIVE_COMPARATOR

Femoral tunnel creation

Intervention Type PROCEDURE

Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned

Interventions

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Femoral tunnel creation

Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention

Exclusion Criteria

* concomitant collateral ligament tears
* significant chondromalacia (based on diagnostic imaging)
* previous lower limb surgery
* significant injury to either lower limb requiring surgery
* history of arthritis
* were unable to comply with rehabilitation protocols or study follow-ups
* were pregnant females or had other medical conditions which precluded participation.
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Panam Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter MacDonald, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Pan Am CLinic/University of Manitoba

Other Identifiers

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ACL-FEM 01

Identifier Type: -

Identifier Source: org_study_id