Prospective, Observational Clinical Investigation of the Exos Reformable Brace

Not Applicable

Completed

• Conditions: Distal Radius Fracture

• Registration Number: NCT03922256
• Lead Sponsor: Foundation for Orthopaedic Research and Education

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Primary Completion: 2019-10-01
• Study Completion: 2020-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
bony union	2-12 weeks	radiographic time to union

Secondary Outcome Measures

Name	Time	Method
Patient rated Wrist Evaluation	2-12 weeks	Rates pain and function on 1(no pain) to 10 (worst pain)
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

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States