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the study stopped becaust the sponsor did not wish to proceede with the study
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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:
The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stimulation of the quadriceps muscle with Myospare | Device |
| Measure | Description | Time Frame |
|---|---|---|
| the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device |
| Measure | Description | Time Frame |
|---|---|---|
| range of movement measured by protractor | ||
| swelling measure by physical examination | ||
| stability of the knee measure by KT1000 |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Meir Libergall, Prof. | Hadassah Medical Organization | Principal Investigator |
| Joseph Lowe, Dr. | Hadassah Medical Organization | Study Director |
| Adi Fridman, Dr. | Hadassah Medical Organization | Study Chair |
| Naama Constantini, Dr. | Hadassah Medical Organization | Study Chair |
| Gabi Agar, Dr. | Asaf Ha'rofe Medical Organization | Study Director |
| Yiftah Bar, Dr. | Asaf Ha'rofe Medical Organization | Study Chair |
| Gideon Man, Dr. | Meir Medical Organization | Study Director |
| Yiftah Hetzroni, Dr. | Meir Medical Organization | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asaf Ha'rofe Orthopedic Department | Beer Yaacov | Israel | ||||
| Hadassah Orthopedic Department |
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| knee history measure by IKDC2000 |
| functional preservation measure by single hop tests and triple hop tests |
| Jerusalem |
| Israel |
| Meir Orthopedic Department | Kfar Saba | Israel |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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