An interventional study of molded brace in Distal Radius Fracture, sponsored by Foundation for Orthopaedic Research and Education. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Foundation for Orthopaedic Research and Education · Not applicable, Interventional, and Treatment
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.
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.
331 studies on the registry are indexed under Wrist Fractures; 71 are open to participants now.
This study's enrollment of 30 is below the median of 64 across 269 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Foundation for Orthopaedic Research and Education is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
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Exclusion
All subjects in this study received the reformable brace
Other: molded 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.
bony union
radiographic time to union
Time frame: 2-12 weeks
Patient Reported Outcomes
Visual Analog Scale from 1(no pain) to 100(extreme pain)
Time frame: 2-12 weeks
Patient Reported Disability Scale- Quick-DASH
11 questions rating ability of activites - ranging from no difficulty to unable to do
Time frame: 2-12 weeks
Patient rated Wrist Evaluation
Rates pain and function on 1(no pain) to 10 (worst pain)
Time frame: 2-12 weeks
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Foundation for Orthopaedic Research and Education