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

Primary Purpose

Osteoarthritis, Knee

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ivivi Torino II
Ivivi Torino II
Sponsored by
Amp Orthopedics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Pulsed Radio Frequency, Electromagnetic Field therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Anderson Orthopaedic Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Targeted pulsed electromagnetic field

Sham

Arm Description

Outcomes

Primary Outcome Measures

The average daily morphine equivalent dose consumption at 2 weeks post-surgery.

Secondary Outcome Measures

Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
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
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
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.
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.
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.

Full Information

First Posted
November 17, 2011
Last Updated
July 6, 2012
Sponsor
Amp Orthopedics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01475604
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amp Orthopedics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Pulsed Radio Frequency, Electromagnetic Field therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted pulsed electromagnetic field
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Ivivi Torino II
Other Intervention Name(s)
Electromagnetic Field Therapy
Intervention Description
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Intervention Type
Device
Intervention Name(s)
Ivivi Torino II
Other Intervention Name(s)
Electromagnetic Field Therapy
Intervention Description
Sham treatment for 4 weeks post-surgery
Primary Outcome Measure Information:
Title
The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
Time Frame
2-week follow-up period from surgery
Secondary Outcome Measure Information:
Title
Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
Time Frame
1 and 4 weeks post-surgery
Title
Knee pain severity assessed on a 10 cm visual analogue scale (VAS)
Description
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
Time Frame
At intervals over the 4-week follow-up period
Title
The measurement of knee joint circumference
Description
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
Time Frame
Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
Title
Range of motion of the knee joint, assessed using the knee flexion technique
Description
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.
Time Frame
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
Title
OA-related medication use including analgesics, anti-inflammatories, and other non-opioids
Description
Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.
Time Frame
4 weeks post-surgery
Title
Adverse Events collected and analyzed for confirmation of device safety
Description
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.
Time Frame
Randomization to 4 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard A. Engh, M.D.
Organizational Affiliation
Anderson Orthopaedic Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anderson Orthopaedic Research Institute
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States

12. IPD Sharing Statement

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

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