Clinical trial NCT00717171: Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair
Official title: Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament
Keywords: electrical stimulation
pain
medication
edema
interferential
neuromuscular
high voltage pulsed current
knee
Lead sponsor: VQ OrthoCare
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ligament repair.


Eligibility 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)

Primary outcomes:
measure: pain
timeFrame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
Secondary outcomes:
measure: pain medications
timeFrame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
measure: edema
timeFrame: post-op days 7, 14, 21, 28, 35, 42
Other outcomes:
Locations:
city: Van Nuys
country: United States
facility: Southern California Orthopedic Institute
state: California
Study officials:
affiliation: Southern California Orthopedic Institute
name: Mark H Getelman, MD
role: PRINCIPAL_INVESTIGATOR
References: