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OpenTrials
Completed

NCT Number: NCT01537588

Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction

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

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Key information

Conditions

Isolated Anterior Cruciate Ligament Rupture

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autograft STG harvest from ACL-deficient leg

Other

Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction

Autograft harvest contralateral to ACL-deficient leg

Other

Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Physical activity

    Time frame: 12 months post-surgery

    7-day record of activity using accelerometer.

Sponsors and collaborators

Lead sponsor

Panam Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2012
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.