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

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

stimulation of the quadriceps muscle with Myospare

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Anterior Cruciate Ligament reconstruction surgery

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Asaf Ha'rofe Orthopedic Department
Hadassah Orthopedic Department
Meir Orthopedic Department

Outcomes

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

Full Information

NCT ID

NCT00312793

First Posted

April 10, 2006

Last Updated

June 21, 2009

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00312793

Brief Title

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

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Terminated

Why Stopped

the study stopped becaust the sponsor did not wish to proceede with the study

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Injuries

Keywords

Anterior Cruciate Ligament reconstruction surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

stimulation of the quadriceps muscle with Myospare

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

range of movement measured by protractor

Title

swelling measure by physical examination

Title

stability of the knee measure by KT1000

Title

knee history measure by IKDC2000

Title

functional preservation measure by single hop tests and triple hop tests

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials: