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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am older than 18 years.
Select...
I have been diagnosed with osteoarthritis.
Select...
I have had knee replacement surgery on one knee.
Select...
I have been diagnosed with osteoarthritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Edema (Swelling)
Pain
Secondary outcome measures
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.
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Who is running the clinical trial?
Center for Joint Surgery and Sports Medicine, MarylandLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 300 lbs.I am older than 18 years.I am having or have had a knee replacement on one side.My affected knee is infected.I have had open surgery on my affected knee.I am older than 18 years.You have a pacemaker or defibrillator implanted in your body.I have been diagnosed with osteoarthritis.I have been diagnosed with Rheumatoid Arthritis.I have had knee replacement surgery on one knee.I have been diagnosed with osteoarthritis.You weigh less than 300 pounds.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Device (Torino II)
- Group 2: Active Device (Torino II)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does Active Device (Torino II) endanger people?
"Our team at Power believes that Active Device (Torino II) is quite safe, awarding it a score of 2. This rating reflects the fact that there are some data concerning its safety but no information on its efficacy yet as this study is in Phase 2."
Answered by AI
Are there still opportunities for enrolment with this medical research?
"Per the information provided on clinicaltrials.gov, this trial is not actively recruiting patients. Initially posted in October of 2010 and last updated in August 2011, it has been supplanted by 612 other studies that are currently seeking participants."
Answered by AI
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