Prospective, Observational Clinical Investigation of the Exos Reformable Brace (EXOS)

February 3, 2020 updated by: Foundation for Orthopaedic Research and Education

Prospective, Observational Clinical Investigation of the Exos® Reformable Brace for Conservatively Managed Distal Radius Fractures: An Evaluation of Time to Union, Satisfaction, and Convenience

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33736
        • Florida Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion

  • Age > 18 years;
  • Unilateral fracture of distal radius without misalignment (dorsal angulation <10°, axial radial shortening <5mm), <2mm intraarticular stepoff;
  • Independent in activities of daily living;
  • Capable and willing of signing informed consent.

Exclusion

  • Children under the age of 18;
  • Fracture of the contralateral arm;
  • Other fractures of the ipsilateral arm;
  • Open fractures;
  • Fractures that require reduction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bony union
Time Frame: 2-12 weeks
radiographic time to union
2-12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes
Time Frame: 2-12 weeks
Visual Analog Scale from 1(no pain) to 100(extreme pain)
2-12 weeks
Patient Reported Disability Scale- Quick-DASH
Time Frame: 2-12 weeks
11 questions rating ability of activites - ranging from no difficulty to unable to do
2-12 weeks
Patient rated Wrist Evaluation
Time Frame: 2-12 weeks
Rates pain and function on 1(no pain) to 10 (worst pain)
2-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Orthopaedic Research and Education

Collaborators

Encore DJO Global

Investigators

  • Principal Investigator: Jason Nydick, MD, Florida Orthopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (ACTUAL)

April 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORE EXOS Brace 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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