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E-Stim and Achilles Tendon Repair Study | Clinical Trials | Clareo Health

COMPLETEDNA

E-Stim and Achilles Tendon Repair Study

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

NCT01833936•Orthopedic Foot and Ankle Center, Ohio

View on ClinicalTrials.gov

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

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

Orthopedic Foot and Ankle Center

Westerville, Ohio, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

September 22, 2016

Completion Date

September 22, 2016

Last Updated

January 10, 2018

Enrollment

ACTUAL participants

Conditions

Achilles Tendon Rupture

Interventions

Compex® muscle stimulator

DEVICE

(inactive) muscle stimulator

DEVICE

Restoring Anatomy of Ruptured Achilles Tendon

NCT06723639

Achilles Tendon Rupture

View study

RECRUITINGNA

Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

NCT03259204

Achilles Tendon RuptureAnkle Fractures+1 more

View study

ACTIVE_NOT_RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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E-Stim and Achilles Tendon Repair Study

Inclusion Criteria

Exclusion Criteria

Restoring Anatomy of Ruptured Achilles Tendon

Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

Early Mobilization After Achilles Tendon Rupture

The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

Development of Achilles Tendon Elongation and Its Effect on Physical Function the First Year After Rupture

Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization