Clinical trial NCT00312793: The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Knee Injuries
Keywords: Anterior Cruciate Ligament reconstruction surgery
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device
Secondary outcomes:
measure: range of movement measured by protractor
measure: swelling measure by physical examination
measure: stability of the knee measure by KT1000
measure: knee history measure by IKDC2000
measure: functional preservation measure by single hop tests and triple hop tests
Other outcomes:
Locations:
city: Beer Yaacov
country: Israel
facility: Asaf Ha'rofe Orthopedic Department
city: Jerusalem
country: Israel
facility: Hadassah Orthopedic Department
city: Kfar Saba
country: Israel
facility: Meir Orthopedic Department
Study officials:
affiliation: Hadassah Medical Organization
name: Meir Libergall, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Joseph Lowe, Dr.
role: STUDY_DIRECTOR
affiliation: Hadassah Medical Organization
name: Adi Fridman, Dr.
role: STUDY_CHAIR
affiliation: Hadassah Medical Organization
name: Naama Constantini, Dr.
role: STUDY_CHAIR
affiliation: Asaf Ha'rofe Medical Organization
name: Gabi Agar, Dr.
role: STUDY_DIRECTOR
affiliation: Asaf Ha'rofe Medical Organization
name: Yiftah Bar, Dr.
role: STUDY_CHAIR
affiliation: Meir Medical Organization
name: Gideon Man, Dr.
role: STUDY_DIRECTOR
affiliation: Meir Medical Organization
name: Yiftah Hetzroni, Dr.
role: STUDY_CHAIR
References: