NCT04287257

PEMF in the Treatment of Fresh Distal Radius Fractures

Status unknown NA Last updated 27 February 2020

What this trial tests

NA trial testing Fracture Healing Patch (FHP) in Distal Radius Fracture in 50 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
1 March 2021

1 March 2022

Quick facts

Lead sponsor	Tel-Aviv Sourasky Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	1 March 2020
Primary completion	1 March 2021
Estimated completion	1 March 2022

Drugs / interventions tested

• Fracture Healing Patch (FHP)

Conditions studied

• Distal Radius Fracture — all drugs for Distal Radius Fracture →

Sponsor

Tel-Aviv Sourasky Medical Center

Who can join

18 and older, any sex, with Distal Radius Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effects of Novel Pulsed Electromagnetic Field Therapy Device on Acute Distal Radius Fractures: A Prospective, Double-Blind, Sham-Controlled, Randomized Pilot Study.
   Factor S, Druckmann I, Atlan F, Rosenblatt Y, et al · · 2023 · cited 10× · PMID 36902653 · DOI 10.3390/jcm12051866
2. The role of electrical stimulation in bone regeneration: mechanistic insights and therapeutic advances.
   Farjaminejad S, Dingle AM. · · 2025 · cited 6× · PMID 40775666 · DOI 10.1186/s42234-025-00180-x