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

Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00717171
• Other study ID #: S060501-ACL
• Status: Terminated
• Phase: Phase 4
• First received: July 14, 2008
• Last updated: January 8, 2009
• Start date: July 2006
• Est. completion date: June 2009

Study information

• Verified date: January 2009
• Source: VQ OrthoCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Southern California Orthopedic Institute	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
VQ OrthoCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain		post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42	No
Secondary	pain medications		post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42	No
Secondary	edema		post-op days 7, 14, 21, 28, 35, 42	No