OrthoCor Advanced System for Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Caerus Corporation

Disqualifiers: Rheumatoid arthritis, Gout, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the OrthoCor Advanced System to determine its effectiveness in reducing pain and improving the quality of life for people with osteoarthritis, a joint disease. The system combines pulsed electromagnetic fields (PEMF) therapy and heat, while an app tracks recovery and activity. Participants will use the system twice daily for four weeks and provide feedback through surveys and tests. It suits individuals who have experienced knee pain for at least three months, have cartilage damage confirmed by imaging, and spend at least two hours a day on their feet. As an unphased trial, this study offers participants a unique opportunity to explore innovative treatment options and contribute to advancing osteoarthritis care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the OrthoCor Advanced System is safe for osteoarthritis patients?

Research shows that Pulsed Electromagnetic Field (PEMF) therapy, used in the OrthoCor Advanced System, is safe and non-invasive. Studies have found that PEMF therapy reduces pain and stiffness and improves movement in people with osteoarthritis. A review of 11 studies found that PEMF therapies significantly improved these symptoms without causing serious side effects. Users of the OrthoCor Active System, which also employs PEMF technology, have reported it as safe and effective for pain relief. To date, no major negative effects have been linked to this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for osteoarthritis, which often involve medications like NSAIDs or physical therapy, the OrthoCor Advanced System is unique because it combines Pulsed Electromagnetic Field (PEMF) therapy with the ability to monitor mobility metrics. PEMF therapy is known for reducing inflammation and promoting healing at the cellular level, offering a non-invasive alternative to traditional pain management methods. Additionally, the system's capability to track mobility metrics provides real-time insights into a patient's progress, potentially enhancing personalized care and improving quality of life. Researchers are excited about this approach because it could offer a novel way to manage osteoarthritis symptoms more effectively and with fewer side effects.

What evidence suggests that the OrthoCor Advanced System is effective for osteoarthritis?

Research has shown that pulsed electromagnetic field (PEMF) therapy, used in the OrthoCor Advanced System, can reduce pain and stiffness and improve movement for people with osteoarthritis. One study found that this therapy significantly lowered pain levels and reduced the need for pain medication in those with joint or soft tissue pain. Another study demonstrated that using the OrthoCor system provided pain relief for people with knee osteoarthritis. These findings suggest that the OrthoCor Advanced System might improve quality of life by easing osteoarthritis symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Joshua G Hackel, MD

Principal Investigator

The Andrews Research & Education Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with osteoarthritis who are seeking to improve their pain and quality of life. Participants will be required to use the OrthoCor Advanced System twice daily and track recovery metrics using an app.

Inclusion Criteria

Willing and able to provide written consent

Prescribed use of the OrthoCor Advanced System

Daily access to a smartphone or tablet compatible with the OrthoCor Medical application

Exclusion Criteria

Unwilling or unable to provide written consent

Unwilling or unable to use the OrthoCor Advanced System

I have not had a cortisone injection, knee surgery, or viscosupplementation in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the OrthoCor Advanced System for 30 minutes twice daily for 4 weeks, with daily recovery measurements and monitoring of mobility metrics

4 weeks

Daily use with remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of range of motion and pain levels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OrthoCor Advanced System

Trial Overview The trial tests if PEMF therapy combined with heat from the OrthoCor Advanced System can relieve symptoms of osteoarthritis. It measures changes in range of motion, sit-to-stand test results, and survey responses after 4 weeks.

How Is the Trial Designed?

Group I: OrthoCor Advanced System Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Caerus Corporation

Lead Sponsor

Trials

2

Recruited

150+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06475677

OrthoCor Advanced Trial for Knee Osteoarthritis The objective of this study is to evaluate the effectiveness of the OrthoCor Advanced System device for relieving symptoms and improving ...

2. orthocormedical.com orthocormedical.com/clinical-evidence/

Clinical Evidence A randomized, multi-site trial found that OrthoCor PST therapy significantly reduced both pain and medication use in patients with joint or soft tissue pain—3- ...

3. orthocormedical.com orthocormedical.com/clinical-evidence/effects-of-pulsed-electromagnetic-field-therapy-on-pain-stiffness-physical-function-and-quality-of-life-in-patients-with-osteoarthritis/

Effects of Pulsed Electromagnetic Field Therapy PEMF therapy shows clinically significant short-term benefits for patients with osteoarthritis, particularly in reducing pain, stiffness, and improving physical ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05244187

Study to Evaluate the OrthoCor Active System for Pain Relief A preliminary study conducted by OrthoCor Medical Inc. in 33 patients suffering from knee osteoarthritis utilizing the OrthCor knee system, showed reduced ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11012419/

Current Evidence Using Pulsed Electromagnetic Fields in ... (3) Results: PEMF therapy demonstrated positive outcomes across various anatomical districts, primarily in knee osteoarthritis. Pain reduction, ...

6. orthocormedical.com orthocormedical.com/privacy-policy/

OrthoCor Privacy Policy Read our privacy policy, detailing our commitment to safeguarding your data and ensuring transparency in how we handle your information.

7. orthocormedical.com orthocormedical.com/

OrthoCor Medical: Noninvasive, Wearable Pain Management ... Experience effective pain management and an improved path to healing with OrthoCor's wearable noninvasive and non-pharmaceutical products.