Dynasplint for Distal Radius Fracture

NCT ID: NCT01032356

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Brief Summary

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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

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Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dynasplint

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

Group Type EXPERIMENTAL

Wrist Extension Dynasplint

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dynasplint Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19487507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18406951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18254105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19194671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15862369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16136342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17254911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16039459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19106803 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 17877939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10968529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17954350 (View on PubMed)

Willis B, Gaspar P, Neffendorf C. Device and Physical Therapy to Unfreeze Shoulder Motion. BioMechanics. 2007 Jan:14(1):45-49

Reference Type BACKGROUND

Other Identifiers

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WED1

Identifier Type: -

Identifier Source: org_study_id

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