Radius Fractures Clinical Trial
Official title:
Comparison of Low Dose Computed Tomography to Conventional Dose Computed Tomography in the Evaluation of Distal Radius Fractures
NCT number | NCT03423043 |
Other study ID # | Pro00089089 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2018 |
Est. completion date | August 25, 2020 |
Verified date | June 2020 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a prospective, departmental funded study examining the outcomes of Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University with a Distal Radius Fracture.
Status | Completed |
Enrollment | 17 |
Est. completion date | August 25, 2020 |
Est. primary completion date | February 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects must be age 18 years or older. - Subject must have sustained an intraarticular distal radius fracture which undergo closed reduction and application of a below-elbow splint. - Subjects whos injury occurred less than 2 weeks prior to the time of enrollment. Exclusion Criteria: - Subject is under the age of 18 years. - Subject is unable to speak English for completion of consent process. - Subject sustained pathologic fracture. - Subject sustained open fracture. - Subject is a pregnant woman. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Arora S, Grover SB, Batra S, Sharma VK. Comparative evaluation of postreduction intra-articular distal radial fractures by radiographs and multidetector computed tomography. J Bone Joint Surg Am. 2010 Nov 3;92(15):2523-32. doi: 10.2106/JBJS.I.01617. — View Citation
Cole RJ, Bindra RR, Evanoff BA, Gilula LA, Yamaguchi K, Gelberman RH. Radiographic evaluation of osseous displacement following intra-articular fractures of the distal radius: reliability of plain radiography versus computed tomography. J Hand Surg Am. 1997 Sep;22(5):792-800. — View Citation
das Graças Nascimento V, da Costa AC, Falcochio DF, Lanzarin LD, Checchia SL, Chakkour I. Computed tomography's influence on the classifications and treatment of the distal radius fractures. Hand (N Y). 2015 Dec;10(4):663-9. doi: 10.1007/s11552-015-9773-8. Epub 2015 Jun 4. — View Citation
Griffey RT, Sodickson A. Cumulative radiation exposure and cancer risk estimates in emergency department patients undergoing repeat or multiple CT. AJR Am J Roentgenol. 2009 Apr;192(4):887-92. doi: 10.2214/AJR.08.1351. — View Citation
Karl JW, Olson PR, Rosenwasser MP. The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma. 2015 Aug;29(8):e242-4. doi: 10.1097/BOT.0000000000000312. — View Citation
Katz MA, Beredjiklian PK, Bozentka DJ, Steinberg DR. Computed tomography scanning of intra-articular distal radius fractures: does it influence treatment? J Hand Surg Am. 2001 May;26(3):415-21. — View Citation
Knirk JL, Jupiter JB. Intra-articular fractures of the distal end of the radius in young adults. J Bone Joint Surg Am. 1986 Jun;68(5):647-59. — View Citation
Konda SR, Goch AM, Leucht P, Christiano A, Gyftopoulos S, Yoeli G, Egol KA. The use of ultra-low-dose CT scans for the evaluation of limb fractures: is the reduced effective dose using ct in orthopaedic injury (REDUCTION) protocol effective? Bone Joint J. 2016 Dec;98-B(12):1668-1673. — View Citation
Konda SR, Howard DO, Gyftopoulos S, Davidovitch RI, Egol KA. Computed tomography scan to detect intra-articular air in the knee joint: a cadaver study to define a low radiation dose imaging protocol. J Orthop Trauma. 2013 Sep;27(9):505-8. doi: 10.1097/BOT.0b013e3182821505. — View Citation
Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451. Review. — View Citation
Sodickson A, Baeyens PF, Andriole KP, Prevedello LM, Nawfel RD, Hanson R, Khorasani R. Recurrent CT, cumulative radiation exposure, and associated radiation-induced cancer risks from CT of adults. Radiology. 2009 Apr;251(1):175-84. doi: 10.1148/radiol.2511081296. — View Citation
Tanabe K, Nakajima T, Sogo E, Denno K, Horiki M, Nakagawa R. Intra-articular fractures of the distal radius evaluated by computed tomography. J Hand Surg Am. 2011 Nov;36(11):1798-803. doi: 10.1016/j.jhsa.2011.08.021. Epub 2011 Oct 5. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low Dose CT Images of Sufficient Diagnostic Quality | Low Dose CT Images will be compared to a standard dose to assess image quality. | 12 months. | |
Secondary | Step Displacement | Representative CT images will be used to measure the step displacement of each fracture. | 12 months | |
Secondary | Gap Displacement | Representative CT images will be used to measure the gap displacement of each fracture. | 12 months |
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