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

November 9, 2016 updated by: Jaskarndip Chahal, University of Toronto Orthopaedic Sports Medicine

The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction - A Multicentre, Patient and Assessor Blinded, Stratified, Two-arm Parallel Group Superiority Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S1B1
        • Women's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: knee flexion angle 2
30 degrees of knee flexion during ACL graft fixation
Procedure: knee flexion angle 2
30 degrees of knee flexion during ACL graft fixation
Other: knee flexion angle 1
0 degrees of knee flexion during ACL graft fixation
Procedure: knee flexion angle 1
0 degrees of knee flexion during ACL graft fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 24 months postoperatively
24 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS scores
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
Marx Activity Score (MAS)
Time Frame: 3, 6, 12, 24 months
3, 6, 12, 24 months
the degree of extension loss in the affected knee (vs. contralateral knee)
Time Frame: 3, 6, 12, and 24 months
the degree of extension in the affected knee as measured by a goniometer
3, 6, 12, and 24 months
Side to side differences in anterior-posterior (AP) stability
Time Frame: 3, 6, 12, and 24 months
differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer
3, 6, 12, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto Orthopaedic Sports Medicine

Collaborators

Arthroscopy Association of North America

Investigators

  • Principal Investigator: Jaskarndip Chahal, MD, University of Toronto Orthopaedic Sports Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTOSM0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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