OrthoCor Advanced Trial for Knee Osteoarthritis
Completed · Not applicable
Conditions studied: Osteoarthritis, Knee, Osteo Arthritis Knee
In brief
The objective of this clinical trial is to show that PEMF therapy, heat, recovery metrics, and compliance data provided by the OrthoCor Advanced System improves pain and quality of life for patients with osteoarthritis. The main question it aims to answer is: Does therapy from the OrthoCor Advanced System improve symptoms of osteoarthritis? Researchers will compare range of motion measurements, sit to stand test results, and functional survey answers to see if there are any changes after 4 weeks of therapy with the OrthoCor Advanced System. Participants will use the OrthoCor Active System for 30 minutes twice daily and complete recovery measurements daily using an application.
Key facts
- Study ID
- NCT06475677
- Run by
- Caerus Corporation
- People needed
- 23
- Starts
- 2024-06-18
- Expected to finish
- 2025-10-06
- Last updated by the study team
- 2025-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Presenting to the study site with knee pain for at least 3 months, with articular cartilage loss confirmed by imaging study
- An initial pain VAS score >4
- At least 2 hours of daily standing and/or walking activity
- Prescribed use of the OrthoCor Advanced System
- Daily access to a smartphone or tablet compatible with the OrthoCor Medical application
- Able to download and install app to smart phone
- Willing and able to provide written consent
- ≥18 years of age
You may not qualify if…
- Previous diagnosis of rheumatoid arthritis or gout
- Cortisone injection, knee surgery, or viscosupplementation in the previous 6 months
- Prior knee replacement
- Have a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump or any active medical implant
- Have an implanted metallic lead or any type of wire coil implant, or any implanted system that may contain a lead
- Known or expected pregnancy
- Have an open wound at the area of application
- Are not able to sense or not fully aware of the sensation of heat
- Have poor circulation or heart disease
- Have uncontrolled diabetes
- Under the age of 18 or individuals with open bone growth plates
- Unwilling or unable to provide written consent
- Unwilling or unable to use the OrthoCor Advanced System
- Unwilling or unable to complete the pain assessment survey
- Enrolled in a study to evaluate an investigational drug
- Prisoner or under incarceration
Where it is running
- Andrews Research & Education Foundation — Gulf Breeze, Florida, United States
Full record on ClinicalTrials.gov
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