Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction

Isolated Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537588
• Other study ID #: April 2009
• Status: Completed
• Phase: N/A
• First received: February 14, 2012
• Last updated: March 9, 2015
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: March 2015
• Source: Panam Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Isolated Anterior Cruciate Ligament Rupture

Intervention

Other:
• Autograft STG harvest from ACL-deficient leg
Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction
• Autograft harvest contralateral to ACL-deficient leg
Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction

Locations

Country	Name	City	State
Canada	Pan Am Clinic	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Panam Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle cross sectional area	Measured on bilateral MRI taken from ischial tuberosity to 10 cm below knee joint line	12 months post-surgery	No
Secondary	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	12-months post-surgery	No
Secondary	Physical activity	7-day record of activity using accelerometer.	12 months post-surgery	No