Clinical trial NCT04287257: PEMF in the Treatment of Fresh Distal Radius Fractures
Official title: Pulsed Electromagnetic Fields in the Treatment of Fresh Distal Radius Fractures. A Prospective, Double Blind, Placebo Controlled, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Subjects with closed unilateral dorsally angulated fracture of the distal radius (Colles') visible by x-ray.
2. Subjects treated conservatively by immobilization ± closed reduction
3. Age \>18 years
4. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.

Exclusion Criteria:

1. Subjects with intra articular fracture or extra-articular fracture that meets the criteria for operative fracture fixation.
2. Subjects with pins or plates in the wrist
3. Sustained previous fractures or bone surgery in the currently fractured distal forearm
4. Synovial pseudarthrosis
5. Subjects with multiple trauma (several fractures at once)
6. Subjects suffering from joint diseases that affect the function of the wrist and/or hand of the injured arm.
7. Pregnancy
8. Women who are breast-feeding.
9. Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
10. presence of a life supporting implanted electronical device

Primary outcomes:
measure: Change from baseline in radiographic fracture healing
timeFrame: Radiographic images (X-ray) will be performed for each subject from day 0 and onward: week 2,4, 6 and 12.
Secondary outcomes:
measure: Change from baseline in improvement of function
timeFrame: Functional assessment will be performed at 4, 6 and 12 weeks from treatment
Other outcomes:
Locations:
Study officials:
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