Fracture, Closed, Comminuted, HealingPhase 3NCT02188836
Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
A Phase 3 study testing Electromagnetic stimulation in people with Fracture, Closed, Comminuted, Healing, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial summary
This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators. The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fracture, Closed, Comminuted, Healing
- What is being tested?
- Electromagnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2008to Oct 2010
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of any sex,
- age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet;
- treated with open or closed reduction and intramedullary reamed blocked nail.
Who cannot join
- Patients were excluded if they had a pathological fracture,
- an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial
This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators.
The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with a placebo device.
Read the detailed description
The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet; treated with open or closed reduction and intramedullary reamed blocked nail.
Patients were excluded if they had a pathological fracture, an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
64 patients were included.
Randomization took place six weeks after fracture day, allocating participants to either one of two groups: group A (electromagnetic stimulation) or group B (placebo).
Each group had a device exactly the same. Patients used the device during one hour every day for eight weeks.
- Conditions
- Fracture, Closed, Comminuted, Healing
- Being tested
- Electromagnetic stimulation, Sham stimulation
- Medical subject headings
- Fractures, Bone, Fractures, Comminuted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic stimulationDevice
Also called "Consolidator"
Electromagnetic stimulation with a new device produced by the investigators for this study.
Sham stimulationDevice
This is a device that look exactly the same to the electrostimulation device, but that does not generate the electromagnetic field. It is a placebo device.
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic device | Experimental | The electromagnetic stimulation was performed by using a device capable of generating an electromagnetic field around the fracture site. This was applied once a day, one hour for 8 weeks. Receives: Device: Electromagnetic stimulation |
| Placebo device | Placebo comparator | A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing
Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.
Measured: up to 18 weerks
Secondary outcomes (1)
Infection
Percentage (%) in each arm which may present an infection.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture, Closed, Comminuted, HealingStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Electromagnetic device
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Martinez, Fundacion Clinica Valle del Lili
- Investigators
- Alfredo Martinez, MD, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188836
- Sponsor's protocol ID
- FemurEMG
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2014
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02188836
- Acronym / sponsor ID
- FemurEMG
- Conditions
- Fracture, Closed, Comminuted, Healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Jul 2014 (estimated)
- 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.
This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators.
The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with a placebo device.
Detailed description
The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet; treated with open or closed reduction and intramedullary reamed blocked nail.
Patients were excluded if they had a pathological fracture, an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
64 patients were included.
Randomization took place six weeks after fracture day, allocating participants to either one of two groups: group A (electromagnetic stimulation) or group B (placebo).
Each group had a device exactly the same. Patients used the device during one hour every day for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Electromagnetic device
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic device | Experimental | Device: Electromagnetic stimulationThe electromagnetic stimulation was performed by using a device capable of generating an electromagnetic field around the fracture site. This was applied once a day, one hour for 8 weeks. |
| Placebo device | Placebo comparator | Device: Sham stimulationA device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of any sex,
- age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet;
- treated with open or closed reduction and intramedullary reamed blocked nail.
Key exclusion criteria (2 listed)
- Patients were excluded if they had a pathological fracture,
- an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
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 |
|---|---|---|
| Electromagnetic stimulationAlso: "Consolidator"Electromagnetic stimulation with a new device produced by the investigators for this study. | Device | Electromagnetic device |
| Sham stimulationThis is a device that look exactly the same to the electrostimulation device, but that does not generate the electromagnetic field. It is a placebo device. | Device | Placebo device |
Primary outcome
Fracture healing
Time frame: up to 18 weerks
Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.
1 secondary outcome
Infection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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.
Alfredo Martinez, MD principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electromagnetic stimulation in people with Fracture, Closed, Comminuted, Healing, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing (time frame: up to 18 weerks). 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 21 Oct 2022.