Prospective, Observational Clinical Investigation of the Exos Reformable Brace
NCT03922256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-02-26
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.
Conditions
- Distal Radius Fracture
Interventions
- 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.
Sponsors & Collaborators
-
Encore DJO Global
collaborator UNKNOWN -
Foundation for Orthopaedic Research and Education
lead OTHER
Principal Investigators
-
Jason Nydick, MD · Florida Orthopaedic Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-08-01
- Primary Completion
- 2019-10-01
- Completion
- 2020-01-30
Countries
- United States
Study Locations
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