PEMF in the Treatment of Fresh Distal Radius Fractures

NCT ID: NCT04287257

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard treatment + Active FHP

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.

Group Type: ACTIVE_COMPARATOR

Fracture Healing Patch (FHP)

Intervention Type: 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 + Sham FHP

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.

Group Type: SHAM_COMPARATOR

Fracture Healing Patch (FHP)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

Head of Research and Developement Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Reut Wengier

Role: CONTACT

reutw@tlvmc.gov.il

36974720 ext. 972

Other Identifiers

0597-19-TLV

Identifier Type: -

Identifier Source: org_study_id