Distal Radius FractureNCT04287257
PEMF in the Treatment of Fresh Distal Radius Fractures
A study testing Fracture Healing Patch (FHP) in people with Distal Radius Fracture, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Fracture Healing Patch (FHP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pulsed Electromagnetic Fields in the Treatment of Fresh Distal Radius Fractures. A Prospective, Double Blind, Placebo Controlled, Randomized Trial
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.
Read more
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
- Being tested
- Fracture Healing Patch (FHP)
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Fracture Healing Patch (FHP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
For assessment of functional deficit, disability and pain level, the Patient Rated Wrist Evaluation (PRWE) will be used. The PRWE is an easy 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability.
Pain Score = Sum of the 5 pain items (out of 50) Best Score = 0, Worst Score = 50 Function Score = Sum of the 10 function items, Divided by 2 (out of 50) Best Score = 0, Worst Score = 50 Computing the Total Score Total Score = Sum of pain + function scores Best Score = 0, Worst Score = 100
Measured: Functional assessment will be performed at 4, 6 and 12 weeks from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287257
- Sponsor's protocol ID
- 0597-19-TLV
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Fields in the Treatment of Fresh Distal Radius Fractures. A Prospective, Double Blind, Placebo Controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT04287257
- Acronym / sponsor ID
- 0597-19-TLV
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + Active FHP | Active comparator | Device: Fracture Healing Patch (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. |
| Standard treatment + Sham FHP | Sham comparator | Device: Fracture Healing Patch (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Standard treatment + Active FHP, Standard treatment + Sham FHP |
Primary outcome
Change from baseline in radiographic fracture healing
Time frame: Radiographic images (X-ray) will be performed for each subject from day 0 and onward: week 2,4, 6 and 12.
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
1 secondary outcome
Change from baseline in improvement of function
Time frame: Functional assessment will be performed at 4, 6 and 12 weeks from treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Fracture Healing Patch (FHP) in people with Distal Radius Fracture, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reut Wengier (36974720 ext. 972, reutw@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in radiographic fracture healing (time frame: Radiographic images (X-ray) will be performed for each subject from day 0 and onward: week 2,4, 6 and 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.