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

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

Sponsors

Lead Sponsor: Amp Orthopedics, Inc.

Source Amp Orthopedics, Inc.
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.

Overall Status Terminated
Start Date November 2011
Completion Date July 2012
Primary Completion Date July 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The average daily morphine equivalent dose consumption at 2 weeks post-surgery. 2-week follow-up period from surgery
Secondary Outcome
Measure 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) At intervals over the 4-week follow-up period
The measurement of knee joint circumference Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
Range of motion of the knee joint, assessed using the knee flexion technique 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
OA-related medication use including analgesics, anti-inflammatories, and other non-opioids 4 weeks post-surgery
Adverse Events collected and analyzed for confirmation of device safety Randomization to 4 weeks post-surgery
Enrollment 23
Condition
Intervention

Intervention Type: Device

Intervention Name: Ivivi Torino II

Description: Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery

Arm Group Label: Targeted pulsed electromagnetic field

Other Name: Electromagnetic Field Therapy

Intervention Type: Device

Intervention Name: Ivivi Torino II

Description: Sham treatment for 4 weeks post-surgery

Arm Group Label: Sham

Other Name: Electromagnetic Field Therapy

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

Gender: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gerard A. Engh, M.D. Principal Investigator Anderson Orthopaedic Research Institute
Location
Facility: Anderson Orthopaedic Research Institute
Location Countries

United States

Verification Date

July 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Targeted pulsed electromagnetic field

Type: Active Comparator

Label: Sham

Type: Sham Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov