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

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

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.

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)