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

NCT ID: NCT00717171

Last Updated: 2009-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-06-30

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.

Conditions

Anterior Cruciate Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: PLACEBO_COMPARATOR

SurgiStim3

Intervention Type: DEVICE

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).

2

Group Type: EXPERIMENTAL

SurgiStim3

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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).

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VQ OrthoCare

INDUSTRY

Sponsor Role: lead

Responsible Party

VQ OrthoCare

Principal Investigators

Mark H Getelman, MD

Role: PRINCIPAL_INVESTIGATOR

Southern California Orthopedic Institute

Locations

Southern California Orthopedic Institute

Van Nuys, California, United States

Countries

United States

Other Identifiers

S060501-ACL

Identifier Type: -

Identifier Source: org_study_id