Status:
COMPLETED
E-Stim and Achilles Tendon Repair Study
Lead Sponsor:
Orthopedic Foot and Ankle Center, Ohio
Collaborating Sponsors:
DonJoy Orthotics
Conditions:
Achilles Tendon Rupture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to the immobilization period necessary to ensure optimal healing. The purpose of this study is to determine if...
Detailed Description
The specific aims of this study are to evaluate the use of electrical stimulation on muscle cross-sectional area and muscle fascicle length following post-operative Achilles tendon surgery. Patients ...
Eligibility Criteria
Inclusion
- 1\. Any patient who is having surgery to treat an acute Achilles tendon rupture or any surgery that involves reflecting or repairing the distal Achilles tendon.
Exclusion
- Body mass index (BMI) greater than or equal to 45
- Inability to consent to participate in clinical research
- Any patient younger than 18 years old
- Any limitations that would interfere with the delivery of electrical stimulation including, but not limited to:
- Presence of an insulin pump
- Pacemaker, defibrillators or other implanted electrical device
- Neurostimulation implants
- History of epilepsy/seizure
- Current pregnancy. A pregnancy test will be performed for any female prior to surgical intervention per hospital protocol unless she is post-menopausal or has been sterilized.
- Active malignancy
- Peripheral neuropathy
- Diabetes Mellitus
- Ischemia of lower limbs
- Active infection
- Following acute trauma or fracture
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01833936
Start Date
January 1 2013
End Date
September 22 2016
Last Update
January 10 2018
Active Locations (1)
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1
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States, 43082