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

NCT00312793 | Terminated Phase 1

• 1 other identifier: ST02-HMO-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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:

1. 1.Physiotherapy plus Myospare
2. 2.Only physiotherapy

Conditions

Knee Injuries

Keywords

Anterior Cruciate Ligament reconstruction surgery

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

stimulation of the quadriceps muscle with Myospare DEVICE

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (3)

Asaf Ha'rofe Orthopedic Department

Beer Yaacov, Israel

Location

Hadassah Orthopedic Department

Jerusalem, Israel

Location

Meir Orthopedic Department

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Meir Libergall, Prof.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Joseph Lowe, Dr.

  Hadassah Medical Organization

  STUDY DIRECTOR

• Adi Fridman, Dr.

  Hadassah Medical Organization

  STUDY CHAIR

• Naama Constantini, Dr.

  Hadassah Medical Organization

  STUDY CHAIR

• Gabi Agar, Dr.

  Asaf Ha'rofe Medical Organization

  STUDY DIRECTOR

• Yiftah Bar, Dr.

  Asaf Ha'rofe Medical Organization

  STUDY CHAIR

• Gideon Man, Dr.

  Meir Medical Organization

  STUDY DIRECTOR

• Yiftah Hetzroni, Dr.

  Meir Medical Organization

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 11, 2006
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

IL (3)