Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00312793
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00312793
Study Brief:
Protocol Section:
NCT00312793