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

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: Distal Radius Fracture
• Intervention / Treatment: Other: molded 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brace Arm; All subjects in this study received the reformable brace	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

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: Encore DJO Global
• Investigators: Principal Investigator: Jason Nydick, MD, Florida Orthopaedic Institute

Study record dates

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Forearm Injuries; Wrist Injuries; Wrist Fractures; Radius Fractures
• 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