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

Phase 4

Terminated

• Conditions: Anterior Cruciate Ligament
• Interventions: Device: SurgiStim3

• Registration Number: NCT00717171
• Lead Sponsor: VQ OrthoCare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-08
• Last Update Posted: 2009-01-12
• Primary Completion: 2009-06
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SurgiStim3	-
2	SurgiStim3	-

Primary Outcome Measures

Name	Time	Method
pain	post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42

Secondary Outcome Measures

Name	Time	Method
pain medications	post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
edema	post-op days 7, 14, 21, 28, 35, 42

Trial Locations

Locations (1)

Southern California Orthopedic Institute; 🇺🇸 Van Nuys, California, United States