PEMF in the Treatment of Fresh Distal Radius Fractures

NCT04287257 | Unknown

• 1 other identifier: 0597-19-TLV
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Change from baseline in radiographic fracture healing

  Change from baseline in radiographic fracture healing will be measured. Radiographic healing will be defined as the interval in days between the occurrence of the fracture and the time when bridging in three of four cortices is seen on X-ray images. A measurement will be made at each follow up evaluation by using Radius Union Scoring System (RUSS) score

  Radiographic images (X-ray) will be performed for each subject from day 0 and onward: week 2,4, 6 and 12.

Secondary Outcomes (1)

• Change from baseline in improvement of function

  Functional assessment will be performed at 4, 6 and 12 weeks from treatment

Study Arms (2)

Standard treatment + Active FHP

ACTIVE COMPARATOR

The PEMF device - FHP (supplied by commercial support) will be placed under the cast in the ER after diagnosing the fracture and will be applied for 24 hours a day continuously for 30-40 days.

Device: Fracture Healing Patch (FHP)

Standard treatment + Sham FHP

SHAM COMPARATOR

Half of the PEMF devices will be not activated at random before the application to the patients. Two types of activators will be provided by the company: active and sham. Sham activated devices will give outward signs of normal function but will not generate a signal. The investigators will be unaware of the device's functionality. The patients will not be able to determine whether the device is working or not. At study completion, device serial numbers will be used to determine which patients received a working device. The company supplying the PEMF-devices will have no knowledge of patient outcome.

Device: Fracture Healing Patch (FHP)

Interventions

Fracture Healing Patch (FHP) DEVICE

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.

Standard treatment + Active FHP; Standard treatment + Sham FHP

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Reut Wengier

CONTACT

36974720; reutw@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Developement Department

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 27, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share