Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction

March 9, 2015 updated by: Panam Clinic

Changes in Muscle Morphology Resulting From ACL Reconstruction: Impact on Strength and Function

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4
        • Pan Am Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle cross sectional area
Time Frame: 12 months post-surgery
Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line
12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee flexion and extension isokinetic strength
Time Frame: 12-months post-surgery
Eccentric anc concentric strength measured at 60, 150, and 270 degrees/second on dynamometer in sitting and in 5 degrees hip flexion
12-months post-surgery
Physical activity
Time Frame: 12 months post-surgery
7-day record of activity using accelerometer.
12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Panam Clinic

Investigators

  • Principal Investigator: Sheila McRae, MSc, University of Manitoba, Pan Am Clinic Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

February 14, 2012

First Submitted That Met QC Criteria

February 17, 2012

First Posted (ESTIMATE)

February 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • April 2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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