The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction
FIRM
1 other identifier
interventional
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedNovember 10, 2016
November 1, 2016
3.8 years
March 27, 2014
November 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
24 months postoperatively
Secondary Outcomes (4)
KOOS scores
3, 6, and 12 months
Marx Activity Score (MAS)
3, 6, 12, 24 months
the degree of extension loss in the affected knee (vs. contralateral knee)
3, 6, 12, and 24 months
Side to side differences in anterior-posterior (AP) stability
3, 6, 12, and 24 months
Study Arms (2)
knee flexion angle 2
OTHER30 degrees of knee flexion during ACL graft fixation
knee flexion angle 1
OTHER0 degrees of knee flexion during ACL graft fixation
Interventions
0 degrees of knee flexion during ACL graft fixation
30 degrees of knee flexion during ACL graft fixation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's College Hospital
Toronto, Ontario, M5S1B1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaskarndip Chahal, MD
University of Toronto Orthopaedic Sports Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 11, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
November 10, 2016
Record last verified: 2016-11