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Wrist Extension Dynasplint (WED) Distal Radius Fracture

Primary Purpose

Distal Radius Fracture, Wrist Contracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wrist Extension Dynasplint
Sponsored by
Dynasplint Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring distal radius fracture, wrist contracture, dynasplint

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental

    Control

    Arm Description

    Patients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint

    Patients will receive standard of care physical therapy and NSAIDS

    Outcomes

    Primary Outcome Measures

    Change in maximal active range of motion in wrist extension

    Secondary Outcome Measures

    Full Information

    First Posted
    April 27, 2012
    Last Updated
    April 30, 2012
    Sponsor
    Dynasplint Systems, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01589627
    Brief Title
    Wrist Extension Dynasplint (WED) Distal Radius Fracture
    Official Title
    Contracture Reduction Following Distal Radius Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dynasplint Systems, Inc.

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Radius Fracture, Wrist Contracture
    Keywords
    distal radius fracture, wrist contracture, dynasplint

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental
    Arm Type
    Experimental
    Arm Description
    Patients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients will receive standard of care physical therapy and NSAIDS
    Intervention Type
    Device
    Intervention Name(s)
    Wrist Extension Dynasplint
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in maximal active range of motion in wrist extension
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stacy Berner, MD
    Organizational Affiliation
    Advanced Centers for Orthopaedic Surgery and Sports Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Wrist Extension Dynasplint (WED) Distal Radius Fracture

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