Dynasplint for Distal Radius Fracture

NCT01032356 | Unknown DMC

• 1 other identifier: WED1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Distal Radius Fracture

Keywords

Distal Radius fracture

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Study Arms (1)

Dynasplint

EXPERIMENTAL

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

Device: Wrist Extension Dynasplint

Interventions

Wrist Extension Dynasplint 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

Dynasplint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

You may not qualify if:

• Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
• Radial nerve entrapment
• Arthrodesis
• Traumatic dislocation of the distal ulna

Sponsors & Collaborators

• Dynasplint Systems, Inc.: lead

Related Publications (14)

• 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

  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.

  PMID: 19487507 BACKGROUND

• 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.

  PMID: 18406951 BACKGROUND

• 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.

  PMID: 18254105 BACKGROUND

• 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.

  PMID: 19194671 BACKGROUND

• 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.

  PMID: 15862369 BACKGROUND

• 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.

  PMID: 16136342 BACKGROUND

• 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.

  PMID: 17254911 BACKGROUND

• 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.

  PMID: 16039459 BACKGROUND

• 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.

  PMID: 19106803 BACKGROUND

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

  PMID: 17877939 BACKGROUND

• 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.

  PMID: 10968529 BACKGROUND

• 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.

  PMID: 17954350 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Last Updated: July 11, 2013

Record last verified: 2013-07