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Prospective, Observational Clinical Investigation of the Exos Reformable Brace — EXOS  

Distal Radius Fracture Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03922256
Study type Interventional
Source Foundation for Orthopaedic Research and Education
Contact
Status Completed
Phase N/A
Start date August 1, 2018
Completion date January 30, 2020
View Details
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