Trial record 8 of 21 for:    Open Studies | "Achilles Tendon"

E-Stim and Achilles Tendon Repair Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Orthopedic Foot and Ankle Center, Ohio
Sponsor:
Collaborator:
Don Joy Orthotics
Information provided by (Responsible Party):
Christopher Hyer, Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier:
NCT01833936
First received: April 12, 2013
Last updated: February 12, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention
Achilles Tendon Rupture
Device: Compex® muscle stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair

Further study details as provided by Orthopedic Foot and Ankle Center, Ohio:

Primary Outcome Measures:
  • Reduce calf muscle atrophy [ Time Frame: 2 weeks, 6 weeks and 12 weeks post-op ] [ Designated as safety issue: No ]
    The use of electrical stimulation will have a positive impact on skeletal muscle cross sectional area and fascicle length. The cross sectional area and the fascicle length will decrease less in the group receiving electrical stimulation compared to the group receiving the sham electrical stimulation.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1- Compex active muscle stimulator
Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.
Device: Compex® muscle stimulator
The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
Sham Comparator: Group 2 -(inactive) muscle stimulator
Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
Device: Compex® muscle stimulator
The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833936

Locations
United States, Ohio
Orthopedic Foot and Ankle Center Recruiting
Westerville, Ohio, United States, 43082
Contact: Emily Stansbury    614-895-2424    ofacresearch@orthofootankle.com   
Contact: Natalie Henke    614-895-8747 ext 187    ofacresearch@orthofootankle.com   
Principal Investigator: Christopher Hyer, DPM, MS         
Sponsors and Collaborators
Orthopedic Foot and Ankle Center, Ohio
Don Joy Orthotics
  More Information

Publications:
Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Use of noninvasive interactive neurostimulation to improve short-term recovery in patients with surgically repaired bimalleolar ankle fractures: a prospective, randomized clinical trial. J Foot Ankle Surg. 2010; 49: 432-437.
Takano Y, Haneda Y, Maeda T, Sakai Y, Matsuse H, Kawaguchi T, Tagawa Y, Shiba N. Increasing muscle strength and mass of thigh in elderly people with the hybrid-training method of electrical stimulation and volitional contraction. Tohoku J. Exp. Med. 2010; 221: 77-85.

Responsible Party: Christopher Hyer, DPM, MS, Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier: NCT01833936     History of Changes
Other Study ID Numbers: OH1-12-00389
Study First Received: April 12, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Orthopedic Foot and Ankle Center, Ohio:
Achilles

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014