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Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

NCT00587795 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-08-02

Study results available
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Summary

Objectives:

\- To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist Fracture Brace for the following cases:

1. Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures;
2. To obtain comparative data between traditional therapies (sugar tong, plaster backslab, long arm or short arm cast) and the use of the StabilAir brace for each patient qualified by specific criteria.

Hypothesis:

1\) For stable, non-displaced fractures, the StabilAir Brace is as effective as a sugar tong splint in the acute setting. 2) In cases where full forearm immobilization is initially preferred, the StabilAir is effective as a follow-up to sugar tong splitting once the need for full immobilization has passed.

Conditions

  • Radius Fractures

Interventions

DEVICE

StabilAir Wrist Brace

Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.

OTHER

Placement of sugar tong splint or plaster cast

Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.

Sponsors & Collaborators

  • AirCast LLC

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • David G Dennison, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-08-31
Completion
2008-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00587795 on ClinicalTrials.gov