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Dynasplint for Distal Radius Fracture

Primary Purpose

Distal Radius Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wrist Extension Dynasplint
Sponsored by
Dynasplint Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal Radius fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dynasplint

    Arm Description

    Patients will be treated with the current standard of care and the Wrist Extension Dynasplint.

    Outcomes

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2009
    Last Updated
    July 10, 2013
    Sponsor
    Dynasplint Systems, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01032356
    Brief Title
    Dynasplint for Distal Radius Fracture
    Official Title
    Contracture Reduction Following Distal Radius Fracture Surgical Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dynasplint Systems, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Radius Fracture
    Keywords
    Distal Radius fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dynasplint
    Arm Type
    Experimental
    Arm Description
    Patients will be treated with the current standard of care and the Wrist Extension Dynasplint.
    Intervention Type
    Device
    Intervention Name(s)
    Wrist Extension Dynasplint
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    Citation
    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
    Results Reference
    background
    PubMed Identifier
    19487507
    Citation
    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. doi: 10.2106/JBJS.H.00448.
    Results Reference
    background
    PubMed Identifier
    18406951
    Citation
    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. doi: 10.1016/j.jhsa.2008.01.005.
    Results Reference
    background
    PubMed Identifier
    18254105
    Citation
    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;2008(1):CD006522. doi: 10.1002/14651858.CD006522.pub2.
    Results Reference
    background
    PubMed Identifier
    19194671
    Citation
    Lai JM, Francisco GE, Willis FB. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study. Adv Ther. 2009 Feb;26(2):241-8. doi: 10.1007/s12325-008-0139-2. Epub 2009 Feb 4.
    Results Reference
    background
    PubMed Identifier
    15862369
    Citation
    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. doi: 10.1016/j.jhsb.2004.12.012. Epub 2005 Apr 8.
    Results Reference
    background
    PubMed Identifier
    16136342
    Citation
    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. doi: 10.1007/s00402-005-0037-x. Epub 2005 Oct 22.
    Results Reference
    background
    PubMed Identifier
    17254911
    Citation
    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. doi: 10.1197/j.jht.2006.11.013.
    Results Reference
    background
    PubMed Identifier
    16039459
    Citation
    Nagy L. Salvage of post-traumatic arthritis following distal radius fracture. Hand Clin. 2005 Aug;21(3):489-98. doi: 10.1016/j.hcl.2005.03.005.
    Results Reference
    background
    PubMed Identifier
    19106803
    Citation
    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. doi: 10.1097/BPB.0b013e328321ce71.
    Results Reference
    background
    PubMed Identifier
    17877939
    Citation
    Shin EK, Jupiter JB. Current concepts in the management of distal radius fractures. Acta Chir Orthop Traumatol Cech. 2007 Aug;74(4):233-46.
    Results Reference
    background
    PubMed Identifier
    10968529
    Citation
    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. doi: 10.1007/pl00013772.
    Results Reference
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    PubMed Identifier
    17954350
    Citation
    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. doi: 10.1197/j.jht.2007.06.001.
    Results Reference
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    Citation
    Willis B, Gaspar P, Neffendorf C. Device and Physical Therapy to Unfreeze Shoulder Motion. BioMechanics. 2007 Jan:14(1):45-49
    Results Reference
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    Dynasplint for Distal Radius Fracture

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