Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty
This study has been terminated.
(Sponsor decision)
Sponsor:
Amp Orthopedics, Inc.
Information provided by (Responsible Party):
Amp Orthopedics, Inc.
ClinicalTrials.gov Identifier:
NCT01475604
First received: November 17, 2011
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee |
Device: Ivivi Torino II |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amp Orthopedics, Inc.:
Primary Outcome Measures:
- The average daily morphine equivalent dose consumption at 2 weeks post-surgery. [ Time Frame: 2-week follow-up period from surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery. [ Time Frame: 1 and 4 weeks post-surgery ] [ Designated as safety issue: No ]
- Knee pain severity assessed on a 10 cm visual analogue scale (VAS) [ Time Frame: At intervals over the 4-week follow-up period ] [ Designated as safety issue: No ]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 [ 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 ] [ Designated as safety issue: No ]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 [ 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 ] [ Designated as safety issue: No ]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 [ Time Frame: 4 weeks post-surgery ] [ Designated as safety issue: No ]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 [ Time Frame: Randomization to 4 weeks post-surgery ] [ Designated as safety issue: No ]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.
| Enrollment: | 23 |
| Study Start Date: | November 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Targeted pulsed electromagnetic field |
Device: Ivivi Torino II
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Other Name: Electromagnetic Field Therapy
|
| Sham Comparator: Sham |
Device: Ivivi Torino II
Sham treatment for 4 weeks post-surgery
Other Name: Electromagnetic Field Therapy
|
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| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475604
Locations
| United States, Virginia | |
| Anderson Orthopaedic Research Institute | |
| Alexandria, Virginia, United States, 22306 | |
Sponsors and Collaborators
Amp Orthopedics, Inc.
Investigators
| Principal Investigator: | Gerard A. Engh, M.D. | Anderson Orthopaedic Research Institute |
More Information
No publications provided
| Responsible Party: | Amp Orthopedics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01475604 History of Changes |
| Other Study ID Numbers: | IOH-TKA-001 |
| Study First Received: | November 17, 2011 |
| Last Updated: | July 6, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Amp Orthopedics, Inc.:
|
Pulsed Radio Frequency, Electromagnetic Field therapy |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 19, 2013