TerminatedPhase 1/2

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

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

Israel60 participants

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00312793

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Knee Injuries trials