Prospective, Observational Clinical Investigation of the Exos Reformable Brace

NCT ID: NCT03922256

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-01-30

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.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brace Arm

All subjects in this study received the reformable brace

Group Type: EXPERIMENTAL

molded brace

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Encore DJO Global

UNKNOWN

Sponsor Role: collaborator

Foundation for Orthopaedic Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Nydick, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Locations

Florida Orthopaedic Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

FORE EXOS Brace 2018

Identifier Type: -

Identifier Source: org_study_id