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

VQ OrthoCare

Status and phase

Terminated

Phase 4

Conditions

Anterior Cruciate Ligament

Treatments

Device: SurgiStim3

Study type

Interventional

Funder types

Industry

Identifiers

NCT00717171

S060501-ACL

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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)