Distal Radius Fracture
Conditions
Brief 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.
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.
Interventions
OTHERmolded brace
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.
Sponsors
Encore DJO Global
Foundation for Orthopaedic Research and Education
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This single-cohort, consecutive series clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion * 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. Exclusion * Children under the age of 18; * Fracture of the contralateral arm; * Other fractures of the ipsilateral arm; * Open fractures; * Fractures that require reduction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bony union | 2-12 weeks | radiographic time to union |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes | 2-12 weeks | Visual Analog Scale from 1(no pain) to 100(extreme pain) |
| Patient Reported Disability Scale- Quick-DASH | 2-12 weeks | 11 questions rating ability of activites - ranging from no difficulty to unable to do |
| Patient rated Wrist Evaluation | 2-12 weeks | Rates pain and function on 1(no pain) to 10 (worst pain) |
Countries
United States
Outcome results
None listed