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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Toronto Orthopaedic Sports Medicine
Sponsor:
Collaborator:
Arthroscopy Association of North America
Information provided by (Responsible Party):
Jaskarndip Chahal, University of Toronto Orthopaedic Sports Medicine
ClinicalTrials.gov Identifier:
NCT02111759
First received: March 27, 2014
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament Injury
Procedure: knee flexion angle 1
Procedure: knee flexion angle 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Toronto Orthopaedic Sports Medicine:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 24 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • KOOS scores [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Marx Activity Score (MAS) [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • the degree of extension loss in the affected knee (vs. contralateral knee) [ Time Frame: 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]
    the degree of extension in the affected knee as measured by a goniometer

  • Side to side differences in anterior-posterior (AP) stability [ Time Frame: 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]
    differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer


Estimated Enrollment: 168
Study Start Date: May 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111759

Contacts
Contact: Jennie Gillis, DC 416-323-6400 ext 7526 j.gillis@utosm.com

Locations
Canada, Ontario
Women's College Hospital Not yet recruiting
Toronto, Ontario, Canada, M5S1B1
Sponsors and Collaborators
University of Toronto Orthopaedic Sports Medicine
Arthroscopy Association of North America
Investigators
Principal Investigator: Jaskarndip Chahal, MD University of Toronto Orthopaedic Sports Medicine
  More Information

No publications provided

Responsible Party: Jaskarndip Chahal, Principal Investigator, University of Toronto Orthopaedic Sports Medicine
ClinicalTrials.gov Identifier: NCT02111759     History of Changes
Other Study ID Numbers: UTOSM0001
Study First Received: March 27, 2014
Last Updated: April 8, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 16, 2014