NCT03922256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 13, 2019

Last Update Submit

February 24, 2025

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • bony union

    radiographic time to union

    2-12 weeks

Secondary Outcomes (3)

  • Patient Reported Outcomes

    2-12 weeks

  • Patient Reported Disability Scale- Quick-DASH

    2-12 weeks

  • Patient rated Wrist Evaluation

    2-12 weeks

Study Arms (1)

Brace Arm

EXPERIMENTAL

All subjects in this study received the reformable brace

Other: molded brace

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.

Brace Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Children under the age of 18;
  • Fracture of the contralateral arm;
  • Other fractures of the ipsilateral arm;
  • Open fractures;
  • Fractures that require reduction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33736, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Jason Nydick, MD

    Florida Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This single-cohort, consecutive series clinical study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

April 19, 2019

Study Start

August 1, 2018

Primary Completion

October 1, 2019

Study Completion

January 30, 2020

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations

US(1)