Osteoarthritis, KneeNCT06475677
OrthoCor Advanced Trial for Knee Osteoarthritis
A study testing OrthoCor Advanced System in people with Osteoarthritis, Knee and Osteo Arthritis Knee, run by Caerus Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteo Arthritis Knee
- What is being tested?
- OrthoCor Advanced System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561
About this study
Official title: Prospective Trial of the OrthoCor Advanced System for Patients With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Osteo Arthritis Knee
- Being tested
- OrthoCor Advanced System
- Keywords
- PEMF, Pulsed ElectroMagnetic Field
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoCor Advanced SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| OrthoCor Advanced System | Experimental | 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. Receives: Device: OrthoCor Advanced System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Primary Safety Endpoint: Number of Adverse Events
Measured: during 4 weeks of treatment
VAS pain score
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
Measured: before, during, and after 4 weeks of treatment
Secondary outcomes (5)
Knee AROM
Active Range of Motion (AROM) for the Knee
Measured: before and after 4 weeks of treatment
Sit-to-stand
Number of times in 30 seconds patient can perform sit-to-stand motion
Measured: before and after 4 weeks of treatment
KOOS survey
Knee injury and Osteoarthritis Outcome Score (KOOS) survey, from 0-100% with 0% indicating the worst function possible and 100% indicating full function
Measured: before and after 4 weeks of treatment
Pain medication use
Daily recording of pain medication taken
Measured: during 4 weeks of treatment
Joint motion tracking
Joint motion tracking data recorded by the application during daily recovery exercises
Measured: during 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start18 Jun 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As osteoarthritis is a chronic condition, outcomes will be compared to baseline measurements for the same participant.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joshua G Hackel, MD, Principal investigator, The Andrews Research & Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475677
- Sponsor's protocol ID
- REP-152
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of the OrthoCor Advanced System for Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06475677
- Acronym / sponsor ID
- REP-152
- Conditions
- Osteoarthritis, Knee, Osteo Arthritis Knee
- Keywords
- PEMF, Pulsed ElectroMagnetic Field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Caerus CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As osteoarthritis is a chronic condition, outcomes will be compared to baseline measurements for the same participant.
| Arm | Type | Receives |
|---|---|---|
| OrthoCor Advanced System | Experimental | Device: OrthoCor Advanced SystemThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthoCor Advanced SystemThe 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. | Device | OrthoCor Advanced System |
Primary outcome
Adverse Events
Time frame: during 4 weeks of treatment
Primary Safety Endpoint: Number of Adverse Events
VAS pain score
Time frame: 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
5 secondary outcomes
Knee AROM
Time frame: before and after 4 weeks of treatment
Sit-to-stand
Time frame: before and after 4 weeks of treatment
KOOS survey
Time frame: before and after 4 weeks of treatment
Pain medication use
Time frame: during 4 weeks of treatment
Joint motion tracking
Time frame: during 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua G Hackel, MD principal investigator
The Andrews Research & Education Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrthoCor Advanced System in people with Osteoarthritis, Knee and Osteo Arthritis Knee, run by Caerus Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: during 4 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.