Status:
TERMINATED
Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair
Lead Sponsor:
VQ OrthoCare
Conditions:
Anterior Cruciate Ligament
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
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 lig...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00717171
Start Date
July 1 2006
End Date
June 1 2009
Last Update
January 12 2009
Active Locations (1)
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1
Southern California Orthopedic Institute
Van Nuys, California, United States, 91405