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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00312793
Recruitment Status : Terminated (the study stopped becaust the sponsor did not wish to proceede with the study)
First Posted : April 11, 2006
Last Update Posted : June 23, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Knee Injuries Device: stimulation of the quadriceps muscle with Myospare Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

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Primary Outcome Measures :
  1. the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device

Secondary Outcome Measures :
  1. range of movement measured by protractor
  2. swelling measure by physical examination
  3. stability of the knee measure by KT1000
  4. knee history measure by IKDC2000
  5. functional preservation measure by single hop tests and triple hop tests


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312793


Locations
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Israel
Asaf Ha'rofe Orthopedic Department
Beer Yaacov, Israel
Hadassah Orthopedic Department
Jerusalem, Israel
Meir Orthopedic Department
Kfar Saba, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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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

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ClinicalTrials.gov Identifier: NCT00312793     History of Changes
Other Study ID Numbers: ST02-HMO-CTIL
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by Hadassah Medical Organization:
Anterior Cruciate Ligament reconstruction surgery

Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries