NCT04287257

PEMF in the Treatment of Fresh Distal Radius Fractures

Pulsed Electromagnetic Fields in the Treatment of Fresh Distal Radius Fractures. A Prospective, Double Blind, Placebo Controlled, Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Distal radial fractures (DRF) are the most common fractures encountered in health care. Annualized estimates in the United States alone suggest an incidence of approximately 640,000 cases, and rising, per year. Most fractures may be treated in a plaster cast, but unstable fractures tend to displace without a surgical procedure. 1 Pulsed electromagnetic field (PEMF) is one modality commonly used to stimulate bone generation throughout various clinical settings including orthoapedic surgery. PEMF has been shown to primarily effect vascular generation, formation and neovascularization2,3. This may help decrease time to healing and allow patients to return to normal activities sooner. Additional study demonstrated that PEMF exposure increased cell proliferation, adhesion and the osteogenic commitment of MSCs, even in inflammatory conditions. In this in-vitro model PEMFs increased the expression of anti-inflammatory cytokines, such as IL-10, and reduced the expression of the pro-inflammatory cytokine IL-1 4. The distal radius fracture was chosen as the model to test the effects of PEMF treatment because it includes both trabecular and cortical bone, is accessible for radiographs, has little soft tissue that can distort the radiograph, and is amenable to multiple functional endpoints. The purpose of the study is to determine whether the use of FHP by means of pulsed electromagnetic fields in acute distal radius fractures will accelerate healing both clinically and radiotralogically

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
DEVICE	Fracture Healing Patch (FHP)	The Fracture Healing Patch (FHP) is an external silicone patch that contains inside micro-electronic modulus, which generates a pulsed electromagnetic field (PEMF) to enhance and improve fracture healing. The FHP is placed under the cast at the fracture site. Throughout the treatment period the FHP produces a pulsed electromagnetic field. The FHP houses a battery, a microelectronic module and a coil that produce the PEMF.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-03-01
• Completion: 2022-03-01
• First posted: 2020-02-27
• Last updated: 2020-02-27