Knee InjuriesPhase 1/2NCT00312793
The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament
A Phase 1/2 study testing stimulation of the quadriceps muscle with Myospare in people with Knee Injuries, run by Hadassah Medical Organization at 3 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- stimulation of the quadriceps muscle with Myospare
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Asaf Ha'rofe Orthopedic Department
Beer Yaacov
Hadassah Orthopedic Department
Jerusalem
Meir Orthopedic Department
Kfar Saba
About this 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)
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.
- Conditions
- Knee Injuries
- Being tested
- stimulation of the quadriceps muscle with Myospare
- Keywords
- Anterior Cruciate Ligament reconstruction surgery
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulation of the quadriceps muscle with MyospareDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
Why it stopped: the study stopped becaust the sponsor did not wish to proceede with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Meir Libergall, Prof., Principal investigator, Hadassah Medical OrganizationJoseph Lowe, Dr., Study director, Hadassah Medical OrganizationAdi Fridman, Dr., Study chair, Hadassah Medical OrganizationNaama Constantini, Dr., Study chair, Hadassah Medical OrganizationGabi Agar, Dr., Study director, Asaf Ha'rofe Medical OrganizationYiftah Bar, Dr., Study chair, Asaf Ha'rofe Medical OrganizationGideon Man, Dr., Study director, Meir Medical OrganizationYiftah Hetzroni, Dr., Study chair, Meir Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312793
- Sponsor's protocol ID
- ST02-HMO-CTIL
- Status last verified
- Jun 2009
- First submitted
- 10 Apr 2006
- Last updated
- 23 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00312793
- Acronym / sponsor ID
- ST02-HMO-CTIL
- Conditions
- Knee Injuries
- Keywords
- Anterior Cruciate Ligament reconstruction surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study stopped becaust the sponsor did not wish to proceede with the study
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 11 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stimulation of the quadriceps muscle with Myospare | Device | – |
Primary outcome
the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: the study stopped becaust the sponsor did not wish to proceede with the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meir Libergall, Prof. principal investigator
Hadassah Medical Organization
Joseph Lowe, Dr. study director
Hadassah Medical Organization
Adi Fridman, Dr. study chair
Hadassah Medical Organization
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing stimulation of the quadriceps muscle with Myospare in people with Knee Injuries, run by Hadassah Medical Organization at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the study stopped becaust the sponsor did not wish to proceede with the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2009.