OrthoCor Advanced Trial for Knee Osteoarthritis

Not Applicable

• Conditions: Osteo Arthritis Knee; Osteoarthritis, Knee
• Interventions: Device: OrthoCor Advanced System

• Registration Number: NCT06475677
• Lead Sponsor: Caerus Corporation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-06-18
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OrthoCor Advanced System	OrthoCor Advanced System	-

Primary Outcome Measures

Name	Time	Method
VAS pain score	before, during, and after 4 weeks of treatment	Primary Efficacy Endpoint: Pain score from 0-10 on the Visual Analog pain Scale (VAS), with 0 indicating no pain and 10 indicating the worst pain imaginable
Adverse Events	during 4 weeks of treatment	Primary Safety Endpoint: Number of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Knee AROM	before and after 4 weeks of treatment	Active Range of Motion (AROM) for the Knee
KOOS survey	before and after 4 weeks of treatment	Knee injury and Osteoarthritis Outcome Score (KOOS) survey, from 0-100% with 0% indicating the worst function possible and 100% indicating full function
Sit-to-stand	before and after 4 weeks of treatment	Number of times in 30 seconds patient can perform sit-to-stand motion
Joint motion tracking	during 4 weeks of treatment	Joint motion tracking data recorded by the application during daily recovery exercises
Pain medication use	during 4 weeks of treatment	Daily recording of pain medication taken

Trial Locations

Locations (1)

Andrews Research & Education Foundation; 🇺🇸 Gulf Breeze, Florida, United States