OrthoCor Advanced Trial for Knee Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Presenting to the study site with knee pain for at least 3 months, with articular cartilage loss confirmed by imaging study. 2. An initial pain VAS score >4. 3. At least 2 hours of daily standing and/or walking activity. 4. Prescribed use of the OrthoCor Advanced System. 5. Daily access to a smartphone or tablet compatible with the OrthoCor Medical application. 6. Able to download and install app to smart phone. 7. Willing and able to provide written consent. 8. ≥18 years of age.

Exclusion Criteria:

1. Previous diagnosis of rheumatoid arthritis or gout. 2. Cortisone injection, knee surgery, or viscosupplementation in the previous 6 months. 3. Prior knee replacement. 4. Have a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump or any active medical implant. 5. Have an implanted metallic lead or any type of wire coil implant, or any implanted system that may contain a lead. 6. Known or expected pregnancy. 7. Have an open wound at the area of application. 8. Are not able to sense or not fully aware of the sensation of heat. 9. Have poor circulation or heart disease. 10. Have uncontrolled diabetes. 11. Under the age of 18 or individuals with open bone growth plates. 12. Unwilling or unable to provide written consent. 13. Unwilling or unable to use the OrthoCor Advanced System. 14. Unwilling or unable to complete the pain assessment survey. 15. Enrolled in a study to evaluate an investigational drug. 16. Prisoner or under incarceration

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06475677
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Caerus Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joshua G Hackel, MD
Principal Investigator Affiliation	The Andrews Research & Education Foundation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee, Osteo Arthritis Knee

Additional Details

Osteoarthritis is a chronic condition characterized by degeneration of the joints, affecting up to 240 million people worldwide.1 Its disabling effects are frequently associated with persistent joint pain, loss of mobility and function, and decreased quality of life that often lead to surgical procedures such as partial or total joint arthroplasty.1 Pulsed Electromagnetic Field (PEMF) therapy is a safe, clinically proven, nonpharmacological therapy that has previously been shown to have beneficial effects on pain and physical function in patients with osteoarthritis.1,2 The OrthoCor Advanced System's novel combination of PEMF with the ability to monitor mobility metrics may have additional beneficial effects on pain, function, and quality of life for individuals affected by osteoarthritis. PEMF is a low-level, time-varying electromagnetic field that passes through and affects superficial soft tissue, helping to accelerate the body's natural anti-inflammatory and recovery responses. PEMF has been shown to stimulate tissue repair pathways that result in pain and inflammation reduction, such as the binding of calcium (Ca2+) to calmodulin (CaM) which triggers an anti-inflammatory nitric oxide (NO) cascade.2-4 NO is a key element in the body's natural healing process. It is also a vasodilator, increasing blood and lymphatic flow.3 Additionally, NO down-regulates interleukin-1 beta (IL1β) and inducible nitric oxide synthase (iNOS), which leads to reduced cyclooxygenase-2 (COX-2) activation and fewer prostaglandins

- molecules responsible for causing inflammation and pain.

5 Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs (NSAIDs), OrthoCor's targeted PEMF signals locally modify these pathways, thereby reducing pain and inflammation without the risks and side effects associated with systemic medication.5.In addition to applying PEMF therapy, the OrthoCor Advanced System features a consumer facing smart device application as well as prescriber portal, allowing direct visibility of therapy compliance, reported pain levels, and functional performance metrics by both patient and physician. Daily recovery measurements may additionally supplement range of motion and joint strengthening and may encourage daily adherence to prescribed physical therapy and exercise. Strengthening exercises are considered a core standard of care treatment for managing knee osteoarthritis.5 Thus, the combined effects of PEMF and recovery insights may provide enhanced benefits to affected patients. The OrthoCor Advanced System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy plus chemical heat from OrthoPods for pain relief in the ankle, back, knee, wrist, elbow, shoulder, foot, or neck, while also providing the user with functional and mobility metrics. The microprocessor delivers the pulsed RF signal to the tissue target via inductive coupling with an applicator coil, while a 9-axis motion sensor tracks joint mobility during therapy. The objective of this study is to evaluate the effectiveness of the OrthoCor Advanced System device for relieving symptoms and improving physical function in patients with osteoarthritis of the knee. It is hypothesized that the OrthoCor Advanced System device will improve knee range of motion and reported quality of life, as well as decrease reported pain levels associated with the knee.

Arms & Interventions

Arms

Experimental: OrthoCor Advanced System

The OrthoCor Advanced System's novel combination of PEMF with the ability to monitor mobility metrics may have additional beneficial effects on pain, function, and quality of life for individuals affected by osteoarthritis.

Interventions

Device: - OrthoCor Advanced System

The OrthoCor Advanced System is a portable battery-operated non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) plus heat therapy for general use pain relief. It utilizes a wrap that positions the device over painful areas and joint motion tracking recorded by a smart device application to monitor recovery metrics and therapy compliance.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Andrews Research & Education Foundation, Gulf Breeze, Florida

Status

Address

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561

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