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

Knee Injuries Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00312793
• Other study ID #: ST02-HMO-CTIL
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 10, 2006
• Last updated: June 21, 2009

Study information

• Verified date: June 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• stimulation of the quadriceps muscle with Myospare

Locations

Country	Name	City	State
Israel	Asaf Ha'rofe Orthopedic Department	Beer Yaacov
Israel	Hadassah Orthopedic Department	Jerusalem
Israel	Meir Orthopedic Department	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device
Secondary	range of movement measured by protractor
Secondary	swelling measure by physical examination
Secondary	stability of the knee measure by KT1000
Secondary	knee history measure by IKDC2000
Secondary	functional preservation measure by single hop tests and triple hop tests