Prospective, Observational Clinical Investigation of the Exos Reformable Brace

NCT03922256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-26

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03922256 on ClinicalTrials.gov