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

NCT01475604 | Terminated Phase 4

• 1 other identifier: IOH-TKA-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Pulsed Radio Frequency, Electromagnetic Field therapy

Outcome Measures

Primary Outcomes (1)

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

  2-week follow-up period from surgery

Secondary Outcomes (6)

• 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

Study Arms (2)

Targeted pulsed electromagnetic field

ACTIVE COMPARATOR

Device: Ivivi Torino II

Sham

SHAM COMPARATOR

Device: Ivivi Torino II

Interventions

Ivivi Torino II DEVICE

Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery

Also known as: Electromagnetic Field Therapy

Targeted pulsed electromagnetic field

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amp Orthopedics, Inc.: lead

Study Sites (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gerard A. Engh, M.D.

  Anderson Orthopaedic Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

US (1)