Back to resultsChanges in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction
Primary Purpose
Isolated Anterior Cruciate Ligament Rupture
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Autograft STG harvest from ACL-deficient leg
Autograft harvest contralateral to ACL-deficient leg
Sponsored by
About this trial
This is an interventional treatment trial for Isolated Anterior Cruciate Ligament Rupture focused on measuring anterior cruciate ligament, hamstring, semitendinosus, gracilis, graft
Eligibility Criteria
Inclusion Criteria:
- between 18 and 50 years old; isolated ACL rupture confirmed on MRI
Exclusion Criteria:
- other physical or mental health issues that affect ability to complete rehabilitation and/or study follow-ups
Sites / Locations
- Pan Am Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Standard
Autograft harvest of STG from ACL-deficient leg
Normal matched
Arm Description
ACL reconstruction with autograft harvest of STG from ACL-deficient leg
Autograft harvest of STG from leg contralateral to ACL-deficient leg
Outcomes
Primary Outcome Measures
Muscle cross sectional area
Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line
Secondary Outcome Measures
Knee flexion and extension isokinetic strength
Eccentric anc concentric strength measured at 60, 150, and 270 degrees/second on dynamometer in sitting and in 5 degrees hip flexion
Physical activity
7-day record of activity using accelerometer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01537588
Brief Title
Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction
Official Title
Changes in Muscle Morphology Resulting From ACL Reconstruction: Impact on Strength and Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Panam Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and apply that knowledge to the treatment and management of patients who undergo anterior cruciate ligament (ACL) reconstruction. There are three main components of this study:
How do muscle shape, size, strength, and ability to function change following hamstring grafting for ACL reconstruction;
How does physical activity change following ACL reconstruction;
Is there a difference in outcome if graft harvest is done from the injured versus uninjured limbs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isolated Anterior Cruciate Ligament Rupture
Keywords
anterior cruciate ligament, hamstring, semitendinosus, gracilis, graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
ACL reconstruction with autograft harvest of STG from ACL-deficient leg
Arm Title
Autograft harvest of STG from ACL-deficient leg
Arm Type
Experimental
Arm Description
Autograft harvest of STG from leg contralateral to ACL-deficient leg
Arm Title
Normal matched
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Autograft STG harvest from ACL-deficient leg
Intervention Description
Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction
Intervention Type
Other
Intervention Name(s)
Autograft harvest contralateral to ACL-deficient leg
Intervention Description
Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction
Primary Outcome Measure Information:
Title
Muscle cross sectional area
Description
Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line
Time Frame
12 months post-surgery
Secondary Outcome Measure Information:
Title
Knee flexion and extension isokinetic strength
Description
Eccentric anc concentric strength measured at 60, 150, and 270 degrees/second on dynamometer in sitting and in 5 degrees hip flexion
Time Frame
12-months post-surgery
Title
Physical activity
Description
7-day record of activity using accelerometer.
Time Frame
12 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
between 18 and 50 years old; isolated ACL rupture confirmed on MRI
Exclusion Criteria:
other physical or mental health issues that affect ability to complete rehabilitation and/or study follow-ups
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila McRae, MSc
Organizational Affiliation
University of Manitoba, Pan Am Clinic Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pan Am Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada
12. IPD Sharing Statement
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Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction
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