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

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
knee flexion angle 1
knee flexion angle 2
Sponsored by
University of Toronto Orthopaedic Sports Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

knee flexion angle 2

knee flexion angle 1

Arm Description

30 degrees of knee flexion during ACL graft fixation

0 degrees of knee flexion during ACL graft fixation

Outcomes

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary Outcome Measures

KOOS scores
Marx Activity Score (MAS)
the degree of extension loss in the affected knee (vs. contralateral knee)
the degree of extension in the affected knee as measured by a goniometer
Side to side differences in anterior-posterior (AP) stability
differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer

Full Information

First Posted
March 27, 2014
Last Updated
November 9, 2016
Sponsor
University of Toronto Orthopaedic Sports Medicine
Collaborators
Arthroscopy Association of North America
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1. Study Identification

Unique Protocol Identification Number
NCT02111759
Brief Title
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction
Acronym
FIRM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto Orthopaedic Sports Medicine
Collaborators
Arthroscopy Association of North America

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
knee flexion angle 2
Arm Type
Other
Arm Description
30 degrees of knee flexion during ACL graft fixation
Arm Title
knee flexion angle 1
Arm Type
Other
Arm Description
0 degrees of knee flexion during ACL graft fixation
Intervention Type
Procedure
Intervention Name(s)
knee flexion angle 1
Intervention Description
0 degrees of knee flexion during ACL graft fixation
Intervention Type
Procedure
Intervention Name(s)
knee flexion angle 2
Intervention Description
30 degrees of knee flexion during ACL graft fixation
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
24 months postoperatively
Secondary Outcome Measure Information:
Title
KOOS scores
Time Frame
3, 6, and 12 months
Title
Marx Activity Score (MAS)
Time Frame
3, 6, 12, 24 months
Title
the degree of extension loss in the affected knee (vs. contralateral knee)
Description
the degree of extension in the affected knee as measured by a goniometer
Time Frame
3, 6, 12, and 24 months
Title
Side to side differences in anterior-posterior (AP) stability
Description
differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer
Time Frame
3, 6, 12, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaskarndip Chahal, MD
Organizational Affiliation
University of Toronto Orthopaedic Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1B1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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