Prospective, Observational Clinical Investigation of the Exos Reformable Brace

Foundation for Orthopaedic Research and Education30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Distal Radius Fracture

Interventions

molded braceOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Florida Orthopaedic Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

bony union

radiographic time to union

Time frame: 2-12 weeks

Secondary Outcomes

Patient Reported Outcomes

Visual Analog Scale from 1(no pain) to 100(extreme pain)

Time frame: 2-12 weeks

Patient Reported Disability Scale- Quick-DASH

11 questions rating ability of activites - ranging from no difficulty to unable to do

Time frame: 2-12 weeks

Patient rated Wrist Evaluation

Rates pain and function on 1(no pain) to 10 (worst pain)

Time frame: 2-12 weeks

Data from ClinicalTrials.gov

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