Prospective, Observational Clinical Investigation of the Exos Reformable Brace

Study Overview
=================
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.

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

Conditions
-----------------
Distal Radius Fracture

Intervention / Treatment
-----------------
* Other: molded brace


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: This single-cohort, consecutive series clinical study.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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