Clinical trial NCT01475604: Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty
Official title: Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty: A Double-Blind, Randomized, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Pulsed Radio Frequency, Electromagnetic Field therapy
Lead sponsor: Amp Orthopedics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
timeFrame: 2-week follow-up period from surgery
Secondary outcomes:
measure: Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
timeFrame: 1 and 4 weeks post-surgery
measure: Knee pain severity assessed on a 10 cm visual analogue scale (VAS)
timeFrame: At intervals over the 4-week follow-up period
measure: The measurement of knee joint circumference
timeFrame: Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
measure: Range of motion of the knee joint, assessed using the knee flexion technique
timeFrame: Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
measure: OA-related medication use including analgesics, anti-inflammatories, and other non-opioids
timeFrame: 4 weeks post-surgery
measure: Adverse Events collected and analyzed for confirmation of device safety
timeFrame: Randomization to 4 weeks post-surgery
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
Study officials:
affiliation: Anderson Orthopaedic Research Institute
name: Gerard A. Engh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: