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Wrist Extension Dynasplint (WED) Distal Radius Fracture

This study is not yet open for participant recruitment.
Verified April 2012 by Dynasplint Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01589627
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Distal Radius Fracture
Wrist Contracture
 Device: Wrist Extension Dynasplint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Contracture Reduction Following Distal Radius Fracture

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Change in maximal active range of motion in wrist extension [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589627

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

No publications provided

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01589627     History of Changes
Other Study ID Numbers: 2009.003
Study First Received: April 27, 2012
Last Updated: April 30, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013