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

Tracking Information
First Received Date ^ICMJE	December 11, 2009
Last Updated Date	April 27, 2012
Start Date ^ICMJE	January 2016
Estimated Primary Completion Date	June 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 13, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01032356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dynasplint for Distal Radius Fracture
Official Title ^ICMJE	Contracture Reduction Following Distal Radius Fracture Surgical Management
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Distal Radius Fracture
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Dynasplint Patients will be treated with the current standard of care and the Wrist Extension Dynasplint. Intervention: Device: Wrist Extension Dynasplint
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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	50
Completion Date	Not Provided
Estimated Primary Completion Date	June 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01032356
Other Study ID Numbers ^ICMJE	WED1
Has Data Monitoring Committee	Yes
Responsible Party	Dynasplint Systems, Inc.
Study Sponsor ^ICMJE	Dynasplint Systems, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dynasplint Systems, Inc.
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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