Status:
TERMINATED
The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Knee Injuries
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00312793
Last Update
June 23 2009
Active Locations (3)
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1
Asaf Ha'rofe Orthopedic Department
Beer Yaacov, Israel
2
Hadassah Orthopedic Department
Jerusalem, Israel
3
Meir Orthopedic Department
Kfar Saba, Israel