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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair|
- pain [ Time Frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
- pain medications [ Time Frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
- edema [ Time Frame: post-op days 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||June 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
The placebo device is programmed to run for the same amount of time, at the same schedule, using the same waveforms as the functional device over the course of the 42 days. The placebo device, however, will only increase to 80% of the patient-set amplitude after a one minute set-up period and will only turn on for 6 seconds of every minute (3s ramp up, 1s on time, 2s ramp down).
Electrical stimulation device that provides interferential, high voltage pulsed current and neuromuscular waveforms in sequence. The device runs continuously for the first 2 days following surgery, then runs 3 times a day for 1 hour on days 3 through 42.
|United States, California|
|Southern California Orthopedic Institute|
|Van Nuys, California, United States, 91405|
|Principal Investigator:||Mark H Getelman, MD||Southern California Orthopedic Institute|