Wrist Extension Dynasplint (WED) Distal Radius Fracture
Contracture Reduction Following Distal Radius Fracture
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 2, 2012
April 1, 2012
April 27, 2012
April 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in maximal active range of motion in wrist extension
12 weeks
Study Arms (2)
experimental
EXPERIMENTALPatients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint
Control
NO INTERVENTIONPatients will receive standard of care physical therapy and NSAIDS
Interventions
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.
Eligibility Criteria
You may qualify if:
- Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up
You may not qualify if:
- Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
- Radial nerve entrapment
- Arthrodesis
- Traumatic dislocation of the distal ulna
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacy Berner, MD
Advanced Centers for Orthopaedic Surgery and Sports Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
May 2, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
May 2, 2012
Record last verified: 2012-04