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

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00312793

Purpose

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:

Physiotherapy plus Myospare
Only physiotherapy

The hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.

Condition	Intervention	Phase
Knee Injuries	Device: stimulation of the quadriceps muscle with Myospare	Phase I Phase II

MedlinePlus related topics: Knee Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device

Secondary Outcome Measures:

range of movement measured by protractor
swelling measure by physical examination
stability of the knee measure by KT1000
knee history measure by IKDC2000
functional preservation measure by single hop tests and triple hop tests

Estimated Enrollment:

60

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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:
- 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312793

Contacts

Contact: Meir Liebergall, Prof.

00972-2-6776342

liebergall@hadassah.org.il

Locations

Israel
Hadassah Orthopedic Department
Jerusalem, Israel
Asaf Ha'rofe Orthopedic Department
Beer Yaacov, Israel
Meir Orthopedic Department
Kfar Saba, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:	Meir Libergall, Prof.	Hadassah Medical Organization
Study Director:	Joseph Lowe, Dr.	Hadassah Medical Organization
Study Chair:	Adi Fridman, Dr.	Hadassah Medical Organization
Study Chair:	Naama Constantini, Dr.	Hadassah Medical Organization
Study Director:	Gabi Agar, Dr.	Asaf Ha'rofe Medical Organization
Study Chair:	Yiftah Bar, Dr.	Asaf Ha'rofe Medical Organization
Study Director:	Gideon Man, Dr.	Meir Medical Organization
Study Chair:	Yiftah Hetzroni, Dr.	Meir Medical Organization

More Information

Study ID Numbers:	ST02-HMO-CTIL
Study First Received:	April 10, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00312793
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Anterior Cruciate Ligament reconstruction surgery

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on January 16, 2009