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Electromagnetic Field Therapy

Pulsed Electromagnetic Fields for Postoperative Knee Pain

Phase 2
Waitlist Available
Research Sponsored by Center for Joint Surgery and Sports Medicine, Maryland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight less than 300 lbs.
Age greater than 18 years
Must not have
Infection of the affected knee
Previous open surgery of the affected knee
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks

Summary

This trial will test whether the Torino II device can help decrease pain and swelling after knee surgery, potentially decreasing the use of narcotic medications.

Who is the study for?
This trial is for adults over 18 years old, under 300 lbs., who are having knee replacement surgery due to osteoarthritis. It's not suitable for those with pacemakers or defibrillators, infected knees, previous open knee surgeries, rheumatoid arthritis history, or regular narcotic use.
What is being tested?
The study tests the Torino II device which emits pulsed electromagnetic fields to see if it reduces pain and swelling after knee surgery and cuts down on the need for post-surgery narcotics.
What are the potential side effects?
While specific side effects aren't listed for this device, similar treatments may cause skin irritation at the site of application or a tingling sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh less than 300 lbs.
Select...
I am older than 18 years.
Select...
I am having or have had a knee replacement on one side.
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I am older than 18 years.
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I have been diagnosed with osteoarthritis.
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I have had knee replacement surgery on one knee.
Select...
I have been diagnosed with osteoarthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My affected knee is infected.
Select...
I have had open surgery on my affected knee.
Select...
I have been diagnosed with Rheumatoid Arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Edema (Swelling)
Pain
Secondary study objectives
Narcotic Pain Medications
Range of Motion

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Device (Torino II)Active Control1 Intervention
Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.
Group II: Sham Device (Torino II)Placebo Group1 Intervention
Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks.

Find a Location

Who is running the clinical trial?

Center for Joint Surgery and Sports Medicine, MarylandLead Sponsor

Media Library

Torino II (Electromagnetic Field Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01415856 — Phase 2
Osteoarthritis Research Study Groups: Sham Device (Torino II), Active Device (Torino II)
Osteoarthritis Clinical Trial 2023: Torino II Highlights & Side Effects. Trial Name: NCT01415856 — Phase 2
Torino II (Electromagnetic Field Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01415856 — Phase 2
~3 spots leftby Dec 2025
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