Distal Radius FractureNCT03154424
Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients
A study testing External fixation in treatment the distal radius fracture in people with Distal Radius Fracture and Multiple Trauma, run by Faculdade de Medicina do ABC.
Trial summary
A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Multiple Trauma, Elderly Person Maltreatment
- What is being tested?
- External fixation in treatment the distal radius fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 May 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- skeletally mature patients, elderly (60 y.o. or more)
- all with a diagnosis of unstable distal radius fractures (AO type A or C)
- associated a multiple injured ( polytrauma ).
Who cannot join
- ongoing chemo or radiotherapy,
- mental illness,
- alcohol abuse.
About this study
Official title: Bridging Versus Non-bridging Dynamic External Fixation in Early Total Care Treatment Unstable Distal Radius Fractures in Elderly Polytrauma Patients: A Randomized Controlled Study
A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®, Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).
Read the detailed description
Dynamic external fixator in the ETC (Early Total Care) of unstable DRFs (distal radius fractures) may be a good choice of treatment. Because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). From this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. Choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested.
Rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.
- Being tested
- External fixation in treatment the distal radius fracture
- Medical subject headings
- Wrist Fractures, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External fixation in treatment the distal radius fractureProcedure or surgery
Compare two techniques
| Study group | Role | What they receive |
|---|---|---|
| Bridging (control group) | Placebo comparator | External fixation in treatment the distal radius fracture Receives: Procedure: External fixation in treatment the distal radius fracture |
| Nonbridging (tested group) | Active comparator | External fixation in treatment the distal radius fracture improve grip strength? Receives: Procedure: External fixation in treatment the distal radius fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strenght
use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist
Measured: 12 months
Secondary outcomes (4)
range of wrist motion
use the specific goniometer to measure the arc of movement the wrist
Measured: 12 months
Radiograph assesment
Measure ulna and radial shortening, tilt palmar
Measured: 12 months
DASH Questionnaire
measure life quality
Measured: 12 months
VAS (visual analog scale)
patient reported outcome (pain) in scale interval (0 until 10)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jun 2015
- Primary completion1 May 2017
- Study completion1 May 2017
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcio Aurelio Aita, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154424
- Sponsor's protocol ID
- 32925713.9.0000.0082
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 16 May 2017
- 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 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Versus Non-bridging Dynamic External Fixation in Early Total Care Treatment Unstable Distal Radius Fractures in Elderly Polytrauma Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03154424
- Acronym / sponsor ID
- 32925713.9.0000.0082
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 16 May 2017 (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.
A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®, Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).
Detailed description
Dynamic external fixator in the ETC (Early Total Care) of unstable DRFs (distal radius fractures) may be a good choice of treatment. Because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). From this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. Choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested.
Rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridging (control group) | Placebo comparator | Procedure: External fixation in treatment the distal radius fractureExternal fixation in treatment the distal radius fracture |
| Nonbridging (tested group) | Active comparator | Procedure: External fixation in treatment the distal radius fractureExternal fixation in treatment the distal radius fracture improve grip strength? |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- skeletally mature patients, elderly (60 y.o. or more)
- all with a diagnosis of unstable distal radius fractures (AO type A or C)
- associated a multiple injured ( polytrauma ).
Key exclusion criteria (3 listed)
- ongoing chemo or radiotherapy,
- mental illness,
- alcohol abuse.
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 |
|---|---|---|
| External fixation in treatment the distal radius fractureCompare two techniques | Procedure or surgery | Bridging (control group), Nonbridging (tested group) |
Primary outcome
Grip strenght
Time frame: 12 months
use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist
4 secondary outcomes
range of wrist motion
Time frame: 12 months
Radiograph assesment
Time frame: 12 months
DASH Questionnaire
Time frame: 12 months
VAS (visual analog scale)
Time frame: 12 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 16 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing External fixation in treatment the distal radius fracture in people with Distal Radius Fracture and Multiple Trauma, run by Faculdade de Medicina do ABC.
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 3 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 16 May 2017. 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?
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?
Grip strenght (time frame: 12 months). 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 16 May 2017.