Distal Radius FractureEXOSNCT03922256
Prospective, Observational Clinical Investigation of the Exos Reformable Brace
A study testing molded brace in people with Distal Radius Fracture, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
This is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable Exos short-arm brace. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- molded brace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years;
- Unilateral fracture of distal radius without misalignment (dorsal angulation <10°, axial radial shortening <5mm), <2mm intraarticular stepoff;
- Independent in activities of daily living;
- Capable and willing of signing informed consent.
Who cannot join
- Children under the age of 18;
- Fracture of the contralateral arm;
- Other fractures of the ipsilateral arm;
- Open fractures;
- Fractures that require reduction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Observational Clinical Investigation of the Exos® Reformable Brace for Conservatively Managed Distal Radius Fractures: An Evaluation of Time to Union, Satisfaction, and Convenience
This is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable Exos short-arm brace.
Read the detailed description
The trial will be a prospective trial of a convenience sample of skeletally mature patients with radiographically-confirmed distal radius fractures that can be managed without ORIF. The study population will be defined as all adult patients (>18 years) with stable, non-displaced distal radius fractures. All patients will be independent in activities of daily living. Patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study PI/coPI will explain all essential elements of the clinical trial. If the patient agrees to participate, the study coordinator or PI/coPI will obtain informed consent. The patient will still be followed clinically per the PI/coPI's standard of care.
- Conditions
- Distal Radius Fracture
- Being tested
- molded brace
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molded braceOther
The moldable brace utilized in the current study will be pre-fabricated and of the short-arm brace variety , which is primarily indicated for non-displaced fractures of the distal radius or distal ulna. The braces are available in multiple sizes for both right and left hands.
| Study group | Role | What they receive |
|---|---|---|
| Brace Arm | Experimental | All subjects in this study received the reformable brace Receives: Other: molded brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
bony union
radiographic time to union
Measured: 2-12 weeks
Secondary outcomes (3)
Patient Reported Outcomes
Visual Analog Scale from 1(no pain) to 100(extreme pain)
Measured: 2-12 weeks
Patient Reported Disability Scale- Quick-DASH
11 questions rating ability of activites - ranging from no difficulty to unable to do
Measured: 2-12 weeks
Patient rated Wrist Evaluation
Rates pain and function on 1(no pain) to 10 (worst pain)
Measured: 2-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Aug 2018
- Primary completion1 Oct 2019
- Study completion30 Jan 2020
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
- Not applicable
- Intervention model
- Sequential
- Model description
- This single-cohort, consecutive series clinical study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Encore DJO Global
- Responsible party
- Sponsor
- Investigators
- Jason Nydick, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922256
- Sponsor's protocol ID
- FORE EXOS Brace 2018
- Acronym
- EXOS
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2019
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Clinical Investigation of the Exos® Reformable Brace for Conservatively Managed Distal Radius Fractures: An Evaluation of Time to Union, Satisfaction, and Convenience
- ClinicalTrials.gov ID
- NCT03922256
- Acronym / sponsor ID
- EXOS / FORE EXOS Brace 2018
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- Encore DJO Global
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 19 Apr 2019 (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.
This is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable Exos short-arm brace.
Detailed description
The trial will be a prospective trial of a convenience sample of skeletally mature patients with radiographically-confirmed distal radius fractures that can be managed without ORIF. The study population will be defined as all adult patients (>18 years) with stable, non-displaced distal radius fractures. All patients will be independent in activities of daily living. Patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study PI/coPI will explain all essential elements of the clinical trial. If the patient agrees to participate, the study coordinator or PI/coPI will obtain informed consent. The patient will still be followed clinically per the PI/coPI's standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-cohort, consecutive series clinical study.
| Arm | Type | Receives |
|---|---|---|
| Brace Arm | Experimental | Other: molded braceAll subjects in this study received the reformable brace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years;
- Unilateral fracture of distal radius without misalignment (dorsal angulation <10°, axial radial shortening <5mm), <2mm intraarticular stepoff;
- Independent in activities of daily living;
- Capable and willing of signing informed consent.
Key exclusion criteria (5 listed)
- Children under the age of 18;
- Fracture of the contralateral arm;
- Other fractures of the ipsilateral arm;
- Open fractures;
- Fractures that require reduction.
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 |
|---|---|---|
| molded braceThe moldable brace utilized in the current study will be pre-fabricated and of the short-arm brace variety , which is primarily indicated for non-displaced fractures of the distal radius or distal ulna. The braces are available in multiple sizes for both right and left hands. | Other | Brace Arm |
Primary outcome
bony union
Time frame: 2-12 weeks
radiographic time to union
3 secondary outcomes
Patient Reported Outcomes
Time frame: 2-12 weeks
Patient Reported Disability Scale- Quick-DASH
Time frame: 2-12 weeks
Patient rated Wrist Evaluation
Time frame: 2-12 weeks
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 26 Feb 2025.
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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.
Jason Nydick, MD principal investigator
Florida Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing molded brace in people with Distal Radius Fracture, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
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 5 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 26 Feb 2025. 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 United States. 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. 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?
bony union (time frame: 2-12 weeks). 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 26 Feb 2025.