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Completed

NCT Number: NCT03922256

Prospective, Observational Clinical Investigation of the Exos Reformable Brace

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Orthopaedic Institute

Tampa, Florida, 33736, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

molded brace

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.

Primary outcomes

  1. bony union

    Time frame: 2-12 weeks

    radiographic time to union

Secondary outcomes

  1. Patient Reported Outcomes

    Time frame: 2-12 weeks

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

  2. Patient Reported Disability Scale- Quick-DASH

    Time frame: 2-12 weeks

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

  3. Patient rated Wrist Evaluation

    Time frame: 2-12 weeks

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

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Collaborators

  • Encore DJO Global

Registry information

Official study 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

Acronym: EXOS

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 19, 2019
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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