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

Foundation for Orthopaedic Research and Education

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Other: molded brace

Study type: Interventional

Funder types: Other

Identifiers

NCT03922256

FORE EXOS Brace 2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Brace Arm

Experimental group

Description:

All subjects in this study received the reformable brace

Treatment:

Other: molded brace