OrthoCor Advanced Trial for Knee Osteoarthritis

NCT06475677 | Completed FDA Device

• 1 other identifier: REP-152
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Osteo Arthritis Knee

Keywords

PEMF; Pulsed ElectroMagnetic Field

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Primary Safety Endpoint: Number of Adverse Events

  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

  before, during, and after 4 weeks of treatment

Secondary Outcomes (5)

• Knee AROM

  before and after 4 weeks of treatment

• Sit-to-stand

  before and after 4 weeks of treatment

• KOOS survey

  before and after 4 weeks of treatment

• Pain medication use

  during 4 weeks of treatment

• Joint motion tracking

  during 4 weeks of treatment

Study Arms (1)

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.

Device: OrthoCor Advanced System

Interventions

OrthoCor Advanced System DEVICE

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.

OrthoCor Advanced System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Caerus Corporation: lead

Study Sites (1)

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Joshua G Hackel, MD

  The Andrews Research & Education Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: As osteoarthritis is a chronic condition, outcomes will be compared to baseline measurements for the same participant.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: June 18, 2024
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)