The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament

June 21, 2009 updated by: Hadassah Medical Organization

Phase 2 Study to Evaluate the Efficacy and Safety of Electronic Stimulation of the Quadriceps Muscle in the Thigh by the MyoSpare Device, in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament (ACL)

This study is designed to evaluate the efficacy and safety of Myospare, a non-invasive device, which is connected to the body via electrodes placed in the injured leg. The electrodes which are placed in the middle or upper thigh will stimulate the quadriceps muscle.

Myospare will be installed 1 day after the anterior cruciate ligament (ACL) reconstruction surgery and will be removed after 6 weeks of treatment. The patients will be assigned to two groups:

  1. Physiotherapy plus Myospare
  2. Only physiotherapy

The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Yaacov, Israel
        • Asaf Ha'rofe Orthopedic Department
      • Jerusalem, Israel
        • Hadassah Orthopedic Department
      • Kfar Saba, Israel
        • Meir Orthopedic Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females between 18-40 years old.
  2. Subjects who are planning to undergo ACL surgery.
  3. The surgery is performed within 3 weeks - 5 years since the injury.
  4. Ability to follow instructions during the study period.
  5. Signed Informed Consent.

Exclusion Criteria:

  1. Bi-lateral surgery of the knee
  2. Recurrent ACL surgery (patients who already underwent ACL surgery)
  3. Complex injuries (a combination of posterior and anterior cruciate and lateral ligament injury)
  4. Patients who underwent or are planned to undergo cartilage implantation.
  5. Patients who underwent or are planned to undergo meniscus stitching.
  6. Additional fracture/s in the lower limbs as a result of the same injury.
  7. Signs of infection in the surgical wounds while installing the Myospare device.
  8. Known skin hypersensitivity.
  9. Known heart disease
  10. Patients with a cardiac pacemaker.
  11. History of peripheral blood vessel disease

  12. Administration of drugs which might disrupt bone metabolism:

    • Total accumulating dosage of 150 gr' prednisone or any other glucocorticoid for seven days or more, within 6 months prior to the trial.
    • Calcitonin for 7 days or more, within 6 months prior to the trial.
    • Bisphosphonates for 30 days or more within 12 months prior to the study.
    • Fluoride for bone strengthening for 30 days or more within 12 months prior to the study.
    • Vitamin D or vitamin D metabolite for bone strengthening for 30 days or more within 12 months prior to the study.
    • Current treatment with chemotherapeutic drugs.
  13. Past or current malignant disease within 10 years of study entry.
  14. Participating in another clinical study during the past four weeks.
  15. Patients who are planned to undergo femoral nerve block.
  16. Patients claiming social security/work accident benefits.
  17. Professional athletes whose livelihood depends on sports.
  18. Pregnant and or lactating women.
  19. Additional symptoms, which in the doctor's opinion would prevent inclusion of the patient in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device

Secondary Outcome Measures

Outcome Measure
range of movement measured by protractor
swelling measure by physical examination
stability of the knee measure by KT1000
knee history measure by IKDC2000
functional preservation measure by single hop tests and triple hop tests

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Meir Libergall, Prof., Hadassah Medical Organization
  • Study Director: Joseph Lowe, Dr., Hadassah Medical Organization
  • Study Chair: Adi Fridman, Dr., Hadassah Medical Organization
  • Study Chair: Naama Constantini, Dr., Hadassah Medical Organization
  • Study Director: Gabi Agar, Dr., Asaf Ha'rofe Medical Organization
  • Study Chair: Yiftah Bar, Dr., Asaf Ha'rofe Medical Organization
  • Study Director: Gideon Man, Dr., Meir Medical Organization
  • Study Chair: Yiftah Hetzroni, Dr., Meir Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 11, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2009

Last Update Submitted That Met QC Criteria

June 21, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST02-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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