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
  Purpose

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.


Condition Intervention Phase
Anterior Cruciate Ligament
Device: SurgiStim3
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by VQ OrthoCare:

Primary Outcome Measures:
  • pain [ Time Frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
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)
Arms Assigned Interventions
Placebo Comparator: 1 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).
Experimental: 2 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717171

Locations
United States, California
Southern California Orthopedic Institute
Van Nuys, California, United States, 91405
Sponsors and Collaborators
VQ OrthoCare
Investigators
Principal Investigator: Mark H Getelman, MD Southern California Orthopedic Institute
  More Information

No publications provided

Responsible Party: Michelle Ocelnik, VQ OrthoCare
ClinicalTrials.gov Identifier: NCT00717171     History of Changes
Other Study ID Numbers: S060501-ACL
Study First Received: July 14, 2008
Last Updated: January 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by VQ OrthoCare:
electrical stimulation
pain
medication
edema
interferential
neuromuscular
high voltage pulsed current
knee

ClinicalTrials.gov processed this record on August 28, 2014