ClinicalTrials.gg
Sign In
TerminatedNCT00312793Updated Jun 23, 2009

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

A Phase 1/2 interventional study of stimulation of the quadriceps muscle with Myospare in Knee Injuries, sponsored by Hadassah Medical Organization. Terminated at 3 sites in Israel. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2009-06-23.

Sponsored by Hadassah Medical Organization · Phase 1/2, Interventional, and Treatment

Why this study was terminated
the study stopped becaust the sponsor did not wish to proceede with the study
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Injuries

Browse trials for

Keywords

  • Anterior Cruciate Ligament reconstruction surgery
03

In context

Knee Injuries

255 studies on the registry are indexed under Knee Injuries; 49 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 165 interventional studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 674 studies on the registry; 55 are open to participants now.

Browse Hadassah Medical Organization studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • Devicestimulation of the quadriceps muscle with Myospare
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. range of movement measured by protractor

  2. swelling measure by physical examination

  3. stability of the knee measure by KT1000

  4. knee history measure by IKDC2000

  5. functional preservation measure by single hop tests and triple hop tests

07

Study locations

3 sites
  • Asaf Ha'rofe Orthopedic Department
    Beer Yaacov, Israel
  • Hadassah Orthopedic Department
    Jerusalem, Israel
  • Meir Orthopedic Department
    Kfar Saba, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00312793
Lead sponsor
Hadassah Medical Organization
First posted
Apr 11, 2006
Last update
Jun 23, 2009

Study contacts

Meir Libergall, Prof.
principal investigator · Hadassah Medical Organization
Joseph Lowe, Dr.
study director · Hadassah Medical Organization
Adi Fridman, Dr.
study chair · Hadassah Medical Organization
Naama Constantini, Dr.
study chair · Hadassah Medical Organization
Gabi Agar, Dr.
study director · Asaf Ha'rofe Medical Organization
Yiftah Bar, Dr.
study chair · Asaf Ha'rofe Medical Organization
Gideon Man, Dr.
study director · Meir Medical Organization
Yiftah Hetzroni, Dr.
study chair · Meir Medical Organization
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Knee Injuries →

Other studies from this sponsor

Hadassah Medical Organization →

Start the discussion