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

NCT00717171 | Terminated Phase 4

• 1 other identifier: S060501-ACL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

electrical stimulation; pain; medication; edema; interferential; neuromuscular; high voltage pulsed current; knee

Outcome Measures

Primary Outcomes (1)

• pain

  post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42

Secondary Outcomes (2)

• pain medications

  post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42

• edema

  post-op days 7, 14, 21, 28, 35, 42

Study Arms (2)

1

PLACEBO COMPARATOR

Device: SurgiStim3

2

EXPERIMENTAL

Device: SurgiStim3

Interventions

SurgiStim3 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.

2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VQ OrthoCare: lead

Study Sites (1)

Southern California Orthopedic Institute

Van Nuys, California, 91405, United States

Location

MeSH Terms

Conditions

Pain; Edema

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark H Getelman, MD

  Southern California Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 12, 2009

Record last verified: 2009-01

Locations

US (1)