Expired Study
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Van Nuys, California 91405


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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)


NCT ID:

NCT00717171


Primary Contact:

Principal Investigator
Mark H Getelman, MD
Southern California Orthopedic Institute


Backup Contact:

N/A


Location Contact:

Van Nuys, California 91405
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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