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NCT01589627 Clinical Trial

Wrist Extension Dynasplint (WED) Distal Radius Fracture

Distal Radius Fracture Clinical Trial

Official title:
Contracture Reduction Following Distal Radius Fracture

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01589627
Other study ID # 2009.003
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 27, 2012
Last updated April 30, 2012
Est. completion date December 2016

Study information
Verified date April 2012
Source Dynasplint Systems, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

Exclusion Criteria:

- Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)

- Radial nerve entrapment

- Arthrodesis

- Traumatic dislocation of the distal ulna

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Wrist Extension Dynasplint
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Dynasplint Systems, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in maximal active range of motion in wrist extension 12 weeks No
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