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The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction

NCT ID: NCT02111759

Last Updated: 2016-11-10

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

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-02-28

Brief Summary

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The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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knee flexion angle 2

30 degrees of knee flexion during ACL graft fixation

Group Type OTHER

knee flexion angle 2

Intervention Type PROCEDURE

30 degrees of knee flexion during ACL graft fixation

knee flexion angle 1

0 degrees of knee flexion during ACL graft fixation

Group Type OTHER

knee flexion angle 1

Intervention Type PROCEDURE

0 degrees of knee flexion during ACL graft fixation

Interventions

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knee flexion angle 1

0 degrees of knee flexion during ACL graft fixation

Intervention Type PROCEDURE

knee flexion angle 2

30 degrees of knee flexion during ACL graft fixation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
* No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
* Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
* surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.

Exclusion Criteria

* Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
* Associated grade III injury to the MCL (medial opening \>10mm at 30 degrees of knee flexion or any medial opening in extension)
* Presence of a PCL or posterolateral corner injury
* Lack of informed consent.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthroscopy Association of North America

OTHER

Sponsor Role collaborator

University of Toronto Orthopaedic Sports Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jaskarndip Chahal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaskarndip Chahal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto Orthopaedic Sports Medicine

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UTOSM0001

Identifier Type: -

Identifier Source: org_study_id