Dynasplint for Distal Radius Fracture

Distal Radius Fracture Clinical Trial

Official title:

Contracture Reduction Following Distal Radius Fracture Surgical Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01032356
• Other study ID #: WED1
• Status: Not yet recruiting
• Phase: N/A
• First received: December 11, 2009
• Last updated: July 10, 2013
• Start date: January 2016

Study information

• Verified date: July 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

References & 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

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. — View 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. — View 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;(1):CD006522. doi: 10.1002/14651858.CD006522.pub2. Review. — View 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. — View 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. Epub 2005 Apr 8. — View 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. Epub 2005 Oct 22. — View 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. — View Citation

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

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No