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

Primary Purpose

Knee Injuries

Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
stimulation of the quadriceps muscle with Myospare
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

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

First Posted
April 10, 2006
Last Updated
June 21, 2009
Sponsor
Hadassah Medical Organization
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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:
First Name & Middle Initial & Last Name & Degree
Meir Libergall, Prof.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Lowe, Dr.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adi Fridman, Dr.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Naama Constantini, Dr.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gabi Agar, Dr.
Organizational Affiliation
Asaf Ha'rofe Medical Organization
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yiftah Bar, Dr.
Organizational Affiliation
Asaf Ha'rofe Medical Organization
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gideon Man, Dr.
Organizational Affiliation
Meir Medical Organization
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yiftah Hetzroni, Dr.
Organizational Affiliation
Meir Medical Organization
Official's Role
Study Chair
Facility Information:
Facility Name
Asaf Ha'rofe Orthopedic Department
City
Beer Yaacov
Country
Israel
Facility Name
Hadassah Orthopedic Department
City
Jerusalem
Country
Israel
Facility Name
Meir Orthopedic Department
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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