Dynasplint for Distal Radius Fracture

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Dynasplint Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01032356
First received: December 11, 2009
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures.


Condition Intervention
Distal Radius Fracture
Device: Wrist Extension Dynasplint

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The dependent variable will be change in maximal, active range of motion in extension and the independent variables will include DASH scores and measurements taken from radiographic imaging [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dynasplint
Patients will be treated with the current standard of care and the Wrist Extension Dynasplint.
Device: Wrist Extension Dynasplint
Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen

  Eligibility

Ages Eligible for Study:   18 Years and older
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
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.

No Contacts or Locations Provided
  More Information

Publications:
1) Berner SH, Willis FB. Treatment of Carpal Tunnel Syndrome with Dynasplint: a Randomized, Controlled Trial. Journal of Medicine, 2008 Dec 1(1), pg 90-94
Lai JM, Francisco GE, Willis FB. Dynamic Splinting on Range of Motion and Spasticity after Treatment with Botulinum Toxin-A: a Randomized, Controlled Pilot Study. Advances in Therapy. 2009 Feb;26(2):241-8
Willis B, Gaspar P, Neffendorf C. Device and Physical Therapy to Unfreeze Shoulder Motion. BioMechanics. 2007 Jan:14(1):45-49

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01032356     History of Changes
Other Study ID Numbers: WED1
Study First Received: December 11, 2009
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:
Distal Radius fracture

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Arm Injuries
Forearm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014