N/A N=40 Randomized Double-blind Prevention

E-Stim and Achilles Tendon Repair Study

Achilles Tendon Rupture

Bottom Line

View on ClinicalTrials.gov: NCT01833936 ↗

Enrolled (actual)

Serious AEs

7.5%

Results posted

Jan 2018

Primary outcome: Primary: Reduce Calf Muscle Atrophy — 859.8; 874.9; 1450.4; 1634.9 mm^2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Compex® muscle stimulator (Device); (inactive) muscle stimulator (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Orthopedic Foot and Ankle Center, Ohio
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduce Calf Muscle Atrophy	859.8; 874.9; 1450.4; 1634.9; 1962.2; 2250.5	—

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.

Eligibility Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01833936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.