A Phase 4 interventional study of Ivivi Torino II and Ivivi Torino II in Osteoarthritis, Knee, sponsored by Amp Orthopedics, Inc.. Terminated at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by Amp Orthopedics, Inc. · Phase 4, Interventional, and Treatment
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.
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 23 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Amp Orthopedics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Ivivi Torino II
Device: Ivivi Torino II
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Also known as: Electromagnetic Field Therapy
Sham treatment for 4 weeks post-surgery
Also known as: Electromagnetic Field Therapy
The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
Time frame: 2-week follow-up period from surgery
Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
Time frame: 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
Time frame: At intervals over the 4-week follow-up period
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
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
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.
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
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.
Time frame: 4 weeks post-surgery
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.
Time frame: Randomization to 4 weeks post-surgery
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Amp Orthopedics, Inc.