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

Amp Orthopedics

Status and phase

Terminated

Phase 4

Conditions

Osteoarthritis, Knee

Treatments

Device: Ivivi Torino II

Study type

Interventional

Funder types

Industry

Identifiers

NCT01475604

IOH-TKA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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