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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT01475604

Run by

Amp Orthopedics, Inc.

People needed

23

Starts

2011-11-01

Expected to finish

2012-07-01

Last updated by the study team

2012-07-10

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anderson Orthopaedic Research Institute — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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