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Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Panam Clinic
ClinicalTrials.gov Identifier:
NCT01537588
First received: February 14, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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:

  1. How do muscle shape, size, strength, and ability to function change following hamstring grafting for ACL reconstruction;
  2. How does physical activity change following ACL reconstruction;
  3. Is there a difference in outcome if graft harvest is done from the injured versus uninjured limbs

Condition Intervention
Isolated Anterior Cruciate Ligament Rupture
Other: Autograft STG harvest from ACL-deficient leg
Other: Autograft harvest contralateral to ACL-deficient leg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Changes in Muscle Morphology Resulting From ACL Reconstruction: Impact on Strength and Function

Resource links provided by NLM:


Further study details as provided by Panam Clinic:

Primary Outcome Measures:
  • Muscle cross sectional area [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line


Secondary Outcome Measures:
  • Knee flexion and extension isokinetic strength [ Time Frame: 12-months post-surgery ] [ Designated as safety issue: No ]
    Eccentric anc concentric strength measured at 60, 150, and 270 degrees/second on dynamometer in sitting and in 5 degrees hip flexion

  • Physical activity [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    7-day record of activity using accelerometer.


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard
ACL reconstruction with autograft harvest of STG from ACL-deficient leg
Other: Autograft STG harvest from ACL-deficient leg
Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction
Experimental: Autograft harvest of STG from ACL-deficient leg
Autograft harvest of STG from leg contralateral to ACL-deficient leg
Other: Autograft harvest contralateral to ACL-deficient leg
Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction
No Intervention: Normal matched

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537588

Locations
Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Sponsors and Collaborators
Panam Clinic
Investigators
Principal Investigator: Sheila McRae, MSc University of Manitoba, Pan Am Clinic Foundation
  More Information

No publications provided

Responsible Party: Panam Clinic
ClinicalTrials.gov Identifier: NCT01537588     History of Changes
Other Study ID Numbers: April 2009
Study First Received: February 14, 2012
Last Updated: April 11, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Panam Clinic:
anterior cruciate ligament
hamstring
semitendinosus
gracilis
graft

ClinicalTrials.gov processed this record on November 20, 2014