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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922256
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Encore DJO Global
Information provided by (Responsible Party):
Foundation for Orthopaedic Research and Education

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.

Outcome Measures
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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)


Eligibility Criteria
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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.
Contacts and Locations
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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
More Information
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Responsible Party: Foundation for Orthopaedic Research and Education
ClinicalTrials.gov Identifier: NCT03922256    
Other Study ID Numbers: FORE EXOS Brace 2018
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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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