Low Dose CT Distal Radius Fractures

Radius Fractures Clinical Trial

Official title:

Comparison of Low Dose Computed Tomography to Conventional Dose Computed Tomography in the Evaluation of Distal Radius Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423043
• Other study ID #: Pro00089089
• Status: Completed
• Start date: July 15, 2018
• Est. completion date: August 25, 2020

Study information

• Verified date: June 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The purpose of this study is to compare the use of a conventional dose computed tomography scan (C-CT) to a low dose computed tomography scan (L-CT) in the assessment of articular displacement, and development of a treatment plan for intraarticular distal radius fractures in an effort to reduce the radiation exposure to future patients with this injury pattern. Reviewers will be tasked with reporting data aimed at investigating 3 primary outcome measures: 1) Are L-CT images of sufficient quality to be used for diagnostic purposes, 2) Can accurate measurements of step and gap displacement be made on L-CT images, 3) Do proposed treatment plans change with the use of L-CT relative to those chosen based on C-CT images We hypothesize that reviewers will find L-CT images of sufficient image quality for diagnostic purposes, measurements of step and gap displacement will not be significantly different between L-CT and C-CT, and no significant differences in treatment options will be chosen based on the use of L-CT rather than C-CT for the same fracture. The secondary aim will be to evaluate the interobserver and intraobserver reliability of L-CT in evaluating intraarticular fractures of the distal radius.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

Intervention

Radiation:
• Low Dose CT Scan of the Wrist
A low dose CT scan will be obtained in patients with a distal radius fracture of the wrist.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

Outcome

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