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

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ClinicalTrials.gov Identifier: NCT02111759
Recruitment Status : Active, not recruiting
First Posted : April 11, 2014
Last Update Posted : November 10, 2016
Sponsor:
Collaborator:
Arthroscopy Association of North America
Information provided by (Responsible Party):
Jaskarndip Chahal, University of Toronto Orthopaedic Sports Medicine

March 27, 2014
April 11, 2014
November 10, 2016
May 2014
February 2018   (Final data collection date for primary outcome measure)
Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 24 months postoperatively ]
Same as current
Complete list of historical versions of study NCT02111759 on ClinicalTrials.gov Archive Site
  • KOOS scores [ Time Frame: 3, 6, and 12 months ]
  • Marx Activity Score (MAS) [ Time Frame: 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
  • 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
Same as current
Not Provided
Not Provided
 
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Anterior Cruciate Ligament Injury
  • Procedure: knee flexion angle 1
    0 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 2
    30 degrees of knee flexion during ACL graft fixation
    Intervention: Procedure: knee flexion angle 2
  • knee flexion angle 1
    0 degrees of knee flexion during ACL graft fixation
    Intervention: Procedure: knee flexion angle 1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
204
168
February 2018
February 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT02111759
UTOSM0001
No
Not Provided
Not Provided
Jaskarndip Chahal, University of Toronto Orthopaedic Sports Medicine
University of Toronto Orthopaedic Sports Medicine
Arthroscopy Association of North America
Principal Investigator: Jaskarndip Chahal, MD University of Toronto Orthopaedic Sports Medicine
University of Toronto Orthopaedic Sports Medicine
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP