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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02111759
Other study ID # UTOSM0001
Secondary ID
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
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