This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
Patients will be treated for distal radius fractures non surgically with a cast or splint
Cadence Health
Winfield, Illinois, United States
University of Missouri
Columbia, Missouri, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Change in Composite Patient Outcomes Over Time
Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.
Time frame: Data will be collected at 2, 6, 12, 26, 52 weeks
Change in Composite Functional Outcomes Over Time
Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes.
Time frame: Data will be collected at 2, 6, 12, 26, 52 weeks
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