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

Study Overview
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Brief Summary
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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: Physiotherapy plus Myospare Only physiotherapy The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.

Official Title
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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)

Conditions
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Knee Injuries

Intervention / Treatment
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* Device: stimulation of the quadriceps muscle with Myospare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18-40 years old. Subjects who are planning to undergo ACL surgery. The surgery is performed within 3 weeks - 5 years since the injury. Ability to follow instructions during the study period. Signed Informed Consent. Exclusion Criteria: Bi-lateral surgery of the knee Recurrent ACL surgery (patients who already underwent ACL surgery) Complex injuries (a combination of posterior and anterior cruciate and lateral ligament injury) Patients who underwent or are planned to undergo cartilage implantation. Patients who underwent or are planned to undergo meniscus stitching. Additional fracture/s in the lower limbs as a result of the same injury. Signs of infection in the surgical wounds while installing the Myospare device. Known skin hypersensitivity. Known heart disease Patients with a cardiac pacemaker. History of peripheral blood vessel disease 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. Past or current malignant disease within 10 years of study entry. Participating in another clinical study during the past four weeks. Patients who are planned to undergo femoral nerve block. Patients claiming social security/work accident benefits. Professional athletes whose livelihood depends on sports. Pregnant and or lactating women. Additional symptoms, which in the doctor's opinion would prevent inclusion of the patient in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: stimulation of the quadriceps muscle with Myospare|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament reconstruction surgery