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

Anterior Cruciate Ligament Injury Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02111759
• Other study ID #: UTOSM0001
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2014
• Last updated: November 9, 2016
• Start date: May 2014
• Est. completion date: February 2018

Study information

• Verified date: November 2016
• Source: University of Toronto Orthopaedic Sports Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 204
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injury

Intervention

Procedure:
• knee flexion angle 1
0 degrees of knee flexion during ACL graft fixation
• knee flexion angle 2
30 degrees of knee flexion during ACL graft fixation

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto Orthopaedic Sports Medicine	Arthroscopy Association of North America

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		24 months postoperatively	No
Secondary	KOOS scores		3, 6, and 12 months	No
Secondary	Marx Activity Score (MAS)		3, 6, 12, 24 months	No
Secondary	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	3, 6, 12, and 24 months	No
Secondary	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	3, 6, 12, and 24 months	No