This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Wrist Extension Dynasplint (WED) Distal Radius Fracture

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Dynasplint Systems, Inc..
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Dynasplint Systems, Inc. Identifier:
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contracture Reduction Following Distal Radius Fracture

Resource links provided by NLM:

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 ]

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01589627

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

Responsible Party: Dynasplint Systems, Inc. Identifier: NCT01589627     History of Changes
Other Study ID Numbers: 2009.003
Study First Received: April 27, 2012
Last Updated: April 30, 2012

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

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases processed this record on September 20, 2017