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

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ClinicalTrials.gov Identifier: NCT03922256
Recruitment Status : Enrolling by invitation
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Encore DJO Global
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Other: molded brace Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Sequential Assignment
Intervention Model Description: This single-cohort, consecutive series clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. bony union [ Time Frame: 2-12 weeks ]
    radiographic time to union


Secondary Outcome Measures :
  1. Patient Reported Outcomes [ Time Frame: 2-12 weeks ]
    Visual Analog Scale from 1(no pain) to 100(extreme pain)

  2. 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

  3. Patient rated Wrist Evaluation [ Time Frame: 2-12 weeks ]
    Rates pain and function on 1(no pain) to 10 (worst pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922256


Locations
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United States, Florida
Florida Orthopaedic Institute
Tampa, Florida, United States, 33736
Sponsors and Collaborators
Foundation for Orthopaedic Research and Education
Encore DJO Global
Investigators
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Principal Investigator: Jason Nydick, MD Florida Orthopaedic Institute

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Responsible Party: Foundation for Orthopaedic Research and Education
ClinicalTrials.gov Identifier: NCT03922256     History of Changes
Other Study ID Numbers: FORE EXOS Brace 2018
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Radius Fractures
Fractures, Bone
Wounds and Injuries
Forearm Injuries
Arm Injuries