Impact of Noninvasive Targeted Pulsed Electromagnetic Fie... | NCT01475604

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 17, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 21, 2011Estimated

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

Jul 6, 2012

Last Update Posted Date

Jul 10, 2012Estimated

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

Description Module

Brief Summary

The purpose of this study is to determine the effectiveness of pulsed radio frequency (PRF), a type of electromagnetic field treatment with the Ivivi Torino II for reducing post-operative narcotic use in patients recovering from Total Knee Arthroplasty.

Detailed Description

Surgeons are continually looking for means to minimize postoperative pain following TKA in order to reduce or eliminate the need for opioid pain medications. Reductions in pain and edema along with improvements in range of motion encourage quicker recovery of joint function and normal activities. Pulsed radio frequency (PRF), a type of electromagnetic field treatment is proven to effectively modulate postoperative pain and edema in plastic surgery. Therefore, PRF has potential as an adjunct therapy for patients recovering from TKA.

The purpose of the current double-blind, randomized, sham-controlled clinical trial is to determine the effectiveness and safety of the Ivivi Torino II, a device that delivers pulsed radio frequency (PRF), a type of electromagnetic field treatment, in patients recovering from TKA for treatment of severe knee OA.

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

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Targeted pulsed electromagnetic field	Active Comparator		Device: Ivivi Torino II
Sham	Sham Comparator		Device: Ivivi Torino II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivivi Torino II	Device	Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery	Targeted pulsed electromagnetic field

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The average daily morphine equivalent dose consumption at 2 weeks post-surgery.		2-week follow-up period from surgery

Secondary Outcomes

Measure	Description	Time Frame
Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.		1 and 4 weeks post-surgery
Knee pain severity assessed on a 10 cm visual analogue scale (VAS)	Knee pain will be assessed for "current", pain at the time of data collection and "maximum", maximum pain experience at any point during the day of evaluation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 40 to 80 years
Primary diagnosis of knee OA
Appropriate candidate for TKA
Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
Consent to the study and willing to comply with study product and methods including follow-up

Exclusion Criteria:

Body mass index > 40 kg/m2
Scheduled for bilateral TKA
Advanced hip, spine, or ankle osteoarthritis that significantly limits ambulation
Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
Use of narcotic pain medication for any condition in the last 1 month prior to surgery
Self-reported diagnosis of post-traumatic or inflammatory arthritis (e.g. rheumatoid or psoriatic)
Pregnant or lactating female
Participation in any clinical trial in the past 30 days
Vulnerable populations including prisoners and nursing home residents
Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerard A. Engh, M.D.	Anderson Orthopaedic Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anderson Orthopaedic Research Institute		Alexandria	Virginia	22306	United States

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases