NCT02436590

Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee

A Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure.

Detailed description

The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure. The primary objective of this study is to prospectively determine, at 12 months post treatment, the safety and efficacy of treating OA of the knee with PEMF. Safety will be assessed through adverse event collection. Study subjects will be randomized in a 2:1 ratio (active: placebo control) to either an active or placebo control (inactive) Physio-Stim device. The study is powered to detect a significant difference between groups when 120 subjects (80 active: 40 placebo control) have completed the study. Planned enrollment for the study is 150 subjects, to allow for an attrition rate of 20%.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Orthofix Physio-Stim Model 3315OA	Active device emits PEMF signal; placebo/control device does not emit PEMF signal

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2015-05-07
• Last updated: 2020-07-14

Locations

2 sites across 1 country: United States