Dynasplint for 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:

NCT01032356

First received: December 11, 2009

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

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

Fanuele J, Koval KJ, Lurie J, Zhou W, Tosteson A, Ring D. Distal radial fracture treatment: what you get may depend on your age and address. J Bone Joint Surg Am. 2009 Jun;91(6):1313-9.

Franko OI, Zurakowski D, Day CS. Functional disability of the wrist: direct correlation with decreased wrist motion. J Hand Surg Am. 2008 Apr;33(4):485-92.

Handoll HH, Huntley JS, Madhok R. Different methods of external fixation for treating distal radial fractures in adults. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006522. Review.

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

Lutz M, Rudisch A, Kralinger F, Smekal V, Goebel G, Gabl M, Pechlaner S. Sagittal wrist motion of carpal bones following intraarticular fractures of the distal radius. J Hand Surg Br. 2005 Jun;30(3):282-7. Epub 2005 Apr 8.

Maciel JS, Taylor NF, McIlveen C. A randomised clinical trial of activity-focussed physiotherapy on patients with distal radius fractures. Arch Orthop Trauma Surg. 2005 Oct;125(8):515-20. Epub 2005 Oct 22.

McKee P, Nguyen C. Customized dynamic splinting: orthoses that promote optimal function and recovery after radial nerve injury: a case report. J Hand Ther. 2007 Jan-Mar;20(1):73-87; quiz 88.

Nagy L. Salvage of post-traumatic arthritis following distal radius fracture. Hand Clin. 2005 Aug;21(3):489-98. Review.

Saini R, Gill SS, Dhillon MS, Goyal T, Wardak E, Prasad P. Results of dorsal approach in surgical correction of congenital vertical talus: an Indian experience. J Pediatr Orthop B. 2009 Mar;18(2):63-8.

Shin EK, Jupiter JB. Current concepts in the management of distal radius fractures. Acta Chir Orthop Traumatol Cech. 2007 Aug;74(4):233-46. Review.

Watt CF, Taylor NF, Baskus K. Do Colles' fracture patients benefit from routine referral to physiotherapy following cast removal? Arch Orthop Trauma Surg. 2000;120(7-8):413-5.

Wilcke MK, Abbaszadegan H, Adolphson PY. Patient-perceived outcome after displaced distal radius fractures. A comparison between radiological parameters, objective physical variables, and the DASH score. J Hand Ther. 2007 Oct-Dec;20(4):290-8; quiz 299.

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:	April 27, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:

Distal Radius fracture

Additional relevant MeSH terms:

Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 16, 2013

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