Back to resultsProspective, Observational Clinical Investigation of the Exos Reformable Brace (EXOS)
Primary Purpose
Distal Radius Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
molded brace
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture
Eligibility 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.
Sites / Locations
- Florida Orthopaedic Institute
Outcomes
Primary Outcome Measures
bony union
radiographic time to union
Secondary Outcome Measures
Patient Reported Outcomes
Visual Analog Scale from 1(no pain) to 100(extreme pain)
Patient Reported Disability Scale- Quick-DASH
11 questions rating ability of activites - ranging from no difficulty to unable to do
Patient rated Wrist Evaluation
Rates pain and function on 1(no pain) to 10 (worst pain)
Full Information
NCT ID
NCT03922256
First Posted
February 13, 2019
Last Updated
February 3, 2020
Sponsor
Foundation for Orthopaedic Research and Education
Collaborators
Encore DJO Global
1. Study Identification
Unique Protocol Identification Number
NCT03922256
Brief Title
Prospective, Observational Clinical Investigation of the Exos Reformable Brace
Acronym
EXOS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Orthopaedic Research and Education
Collaborators
Encore DJO Global
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This single-cohort, consecutive series clinical study.
Masking
None (Open Label)
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
molded brace
Intervention Description
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 Measure Information:
Title
bony union
Description
radiographic time to union
Time Frame
2-12 weeks
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes
Description
Visual Analog Scale from 1(no pain) to 100(extreme pain)
Time Frame
2-12 weeks
Title
Patient Reported Disability Scale- Quick-DASH
Description
11 questions rating ability of activites - ranging from no difficulty to unable to do
Time Frame
2-12 weeks
Title
Patient rated Wrist Evaluation
Description
Rates pain and function on 1(no pain) to 10 (worst pain)
Time Frame
2-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Nydick, MD
Organizational Affiliation
Florida Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Orthopaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33736
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prospective, Observational Clinical Investigation of the Exos Reformable Brace
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