Efficacy of the SurgiStim3 Electrical Stimulation Device... | NCT00717171

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

NCT00717171

Sponsor

VQ OrthoCare

Status

Terminated

Last Update Posted

Jan 12, 2009Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Anterior Cruciate Ligament

Interventions

SurgiStim3
SurgiStim3

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Jun 2009Estimated

Completion Date

Jun 2009Estimated

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2009

Last Update Posted Date

Jan 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Device: SurgiStim3
2	Experimental		Device: SurgiStim3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
pain		post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42

Measure	Description	Time Frame
pain medications		post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
edema		post-op days 7, 14, 21, 28, 35, 42

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010146	Pain
D004487	Edema

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms