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Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty

NCT ID: NCT01475604

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Keywords

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Pulsed Radio Frequency, Electromagnetic Field therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Targeted pulsed electromagnetic field

Group Type ACTIVE_COMPARATOR

Ivivi Torino II

Intervention Type DEVICE

Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery

Sham

Group Type SHAM_COMPARATOR

Ivivi Torino II

Intervention Type DEVICE

Sham treatment for 4 weeks post-surgery

Interventions

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Ivivi Torino II

Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery

Intervention Type DEVICE

Ivivi Torino II

Sham treatment for 4 weeks post-surgery

Intervention Type DEVICE

Other Intervention Names

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Electromagnetic Field Therapy Electromagnetic Field Therapy

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amp Orthopedics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard A. Engh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Anderson Orthopaedic Research Institute

Locations

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Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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IOH-TKA-001

Identifier Type: -

Identifier Source: org_study_id