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Dynasplint for Distal Radius Fracture

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ClinicalTrials.gov Identifier: NCT01032356
Recruitment Status : Unknown
Verified July 2013 by Dynasplint Systems, Inc..
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2009
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.

Brief Summary:
The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Device: Wrist Extension Dynasplint Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contracture Reduction Following Distal Radius Fracture Surgical Management
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dynasplint
Patients will be treated with the current standard of care and the Wrist Extension Dynasplint.
Device: Wrist Extension Dynasplint
Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen



Primary Outcome Measures :
  1. The dependent variable will be change in maximal, active range of motion in extension and the independent variables will include DASH scores and measurements taken from radiographic imaging [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
1) Berner SH, Willis FB. Treatment of Carpal Tunnel Syndrome with Dynasplint: a Randomized, Controlled Trial. Journal of Medicine, 2008 Dec 1(1), pg 90-94
Willis B, Gaspar P, Neffendorf C. Device and Physical Therapy to Unfreeze Shoulder Motion. BioMechanics. 2007 Jan:14(1):45-49

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01032356     History of Changes
Other Study ID Numbers: WED1
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Dynasplint Systems, Inc.:
Distal Radius fracture

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries