Prospective, Observational Clinical Investigation of the Exos Reformable Brace

Distal Radius Fracture Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922256
• Other study ID #: FORE EXOS Brace 2018
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2020
• Source: Foundation for Orthopaedic Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Radius Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education	Encore DJO Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bony union	radiographic time to union	2-12 weeks
Secondary	Patient Reported Outcomes	Visual Analog Scale from 1(no pain) to 100(extreme pain)	2-12 weeks
Secondary	Patient Reported Disability Scale- Quick-DASH	11 questions rating ability of activites - ranging from no difficulty to unable to do	2-12 weeks
Secondary	Patient rated Wrist Evaluation	Rates pain and function on 1(no pain) to 10 (worst pain)	2-12 weeks