Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Anterior Cruciate Ligament

In brief

The purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair.

Key facts

Study ID

NCT00717171

Run by

VQ OrthoCare

People needed

100

Starts

2006-07-01

Expected to finish

2009-06-01

Last updated by the study team

2009-01-12

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Agree to provide informed consent to be included within this ACL study
• Demonstrate a continued willingness to be compliant with the parameters established under the study;
• Have no history of drug or alcohol abuse in the last 2 years;
• Be either a male or female adult between the ages of 18 and 64;
• Be undergoing a surgical repair of the anterior cruciate ligament (ACL) using either a hamstring, patella tendon, Achilles tendon, or allograft procedure; and
• Understand that there is no financial remuneration for participation in the study.

You may not qualify if…

• Pregnant women
• Insulin dependent diabetic patients
• Patients with a demand type pacemaker
• Patients who have a malignant tumor (other than basal cell epithelioma)
• Patients with a known history of alcohol or drug abuse in the last 2 years
• Patients who will not agree to provide informed consent to be included within this ACL study
• Patients who demonstrate a continued unwillingness to be compliant with the parameters established under this study.
• "Poor healers" as identified by the patient's medical history
• Patients who have a history of sensitivity to surgical tape, electrode adhesives, etc.
• Patients with a known history of RSD (reflex sympathetic dystrophy)
• Patients with a history of chronic pain (on opiates or high dosage of NSAIDS for 3 months or greater)
• Patients who have previously undergone an ACL reconstruction on the same knee
• Patients with clinically varicose veins (clinically significant or symptomatic)
• Patients whose history shows an abuse of diuretics or anti-inflammatory medications
• Patients who will undergo multiple ligament surgery (i.e., ACL plus PCL, MCL, and/or LCL)

Where it is running

• Southern California Orthopedic Institute — Van Nuys, California, United States

Full record on ClinicalTrials.gov

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