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

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by:
VQ OrthoCare
ClinicalTrials.gov Identifier:
NCT00717171
First received: July 14, 2008
Last updated: January 8, 2009
Last verified: January 2009

July 14, 2008
January 8, 2009
July 2006
June 2009   (final data collection date for primary outcome measure)
pain [ Time Frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00717171 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anterior Cruciate Ligament
  • Device: SurgiStim3
    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.
  • Device: SurgiStim3
    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).
  • Placebo Comparator: 1
    Intervention: Device: SurgiStim3
  • Experimental: 2
    Intervention: Device: SurgiStim3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
June 2009
June 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717171
S060501-ACL
No
Michelle Ocelnik, VQ OrthoCare
VQ OrthoCare
Not Provided
Principal Investigator: Mark H Getelman, MD Southern California Orthopedic Institute
VQ OrthoCare
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP