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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01475604
• Other study ID #: IOH-TKA-001
• Status: Terminated
• Phase: Phase 4
• First received: November 17, 2011
• Last updated: July 6, 2012
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Amp Orthopedics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Ivivi Torino II
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
• Ivivi Torino II
Sham treatment for 4 weeks post-surgery

Locations

Country	Name	City	State
United States	Anderson Orthopaedic Research Institute	Alexandria	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Amp Orthopedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average daily morphine equivalent dose consumption at 2 weeks post-surgery.		2-week follow-up period from surgery	No
Secondary	Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.		1 and 4 weeks post-surgery	No
Secondary	Knee pain severity assessed on a 10 cm visual analogue scale (VAS)	Knee pain will be assessed for "current", pain at the time of data collection and "maximum", maximum pain experience at any point during the day of evaluation	At intervals over the 4-week follow-up period	No
Secondary	The measurement of knee joint circumference	With patient in supine position, the circumference of the extended knee will be measured 1 cm proximal to the base of the patella using the same type of tape measure in all patients	Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit	No
Secondary	Range of motion of the knee joint, assessed using the knee flexion technique	Range of motion will be assessed using the knee flexion technique, which allows the use of a goniometer with the trans-epicondylar axis of the knee joint as the fulcrum.	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	No
Secondary	OA-related medication use including analgesics, anti-inflammatories, and other non-opioids	Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.	4 weeks post-surgery	No
Secondary	Adverse Events collected and analyzed for confirmation of device safety	Subjects will be instructed by the research staff and in the instructions in the daily diary to contact the research staff and/or investigator with any adverse events (AEs). Adverse events will be recorded daily.	Randomization to 4 weeks post-surgery	No