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
About this trial
This is an interventional treatment trial for Distal Radius Fracture focused on measuring distal radius fracture, wrist contracture, dynasplint
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
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
NCT ID
NCT01589627
First Posted
April 27, 2012
Last Updated
April 30, 2012
Sponsor
Dynasplint Systems, Inc.
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
Learn more about this trial
Wrist Extension Dynasplint (WED) Distal Radius Fracture
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