E-Stim and Achilles Tendon Repair Study



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/12/2018
Start Date:January 2013
End Date:September 22, 2016

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The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair

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 the use of neuromuscular electrical stimulation
(NMES) after Achilles tendon surgery will reduce calf muscle atrophy.

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 will be randomly assigned to receive an electrical stimulation unit (Compex®, DJO
Global, San Diego, CA). Twenty of these units will be experimental and 20 will be sham.

Inclusion Criteria:

- 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 Criteria:

1. Body mass index (BMI) greater than or equal to 45

2. Inability to consent to participate in clinical research

3. Any patient younger than 18 years old

4. Any limitations that would interfere with the delivery of electrical stimulation
including, but not limited to:

1. Presence of an insulin pump

2. Pacemaker, defibrillators or other implanted electrical device

3. Neurostimulation implants

4. History of epilepsy/seizure

5. 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.

6. Active malignancy

7. Peripheral neuropathy

8. Diabetes Mellitus

9. Ischemia of lower limbs

10. Active infection

11. Following acute trauma or fracture
We found this trial at
1
site
Westerville, Ohio 43082
Principal Investigator: Christopher Hyer, DPM, MS
Phone: 614-895-2424
?
mi
from
Westerville, OH
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