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Wrist Extension Dynasplint (WED) Distal Radius Fracture

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ClinicalTrials.gov Identifier: NCT01589627
Recruitment Status : Unknown
Verified April 2012 by Dynasplint Systems, Inc..
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2012
Last Update Posted : May 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Distal Radius Fracture Wrist Contracture Device: Wrist Extension Dynasplint

Study Design

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: experimental
Patients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint
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.
No Intervention: Control
Patients will receive standard of care physical therapy and NSAIDS


Outcome Measures

Primary Outcome Measures :
  1. Change in maximal active range of motion in wrist extension [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589627


Sponsors and Collaborators
Dynasplint Systems, Inc.
Investigators
Principal Investigator: Stacy Berner, MD Advanced Centers for Orthopaedic Surgery and Sports Medicine
More Information

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01589627     History of Changes
Other Study ID Numbers: 2009.003
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012

Keywords provided by Dynasplint Systems, Inc.:
distal radius fracture
wrist contracture
dynasplint

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Contracture
Wounds and Injuries
Forearm Injuries
Arm Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases