Low Dose CT Distal Radius Fractures

NCT03423043 | Completed DMC FDA Device

• 1 other identifier: Pro00089089
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radius Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Step Displacement

  12 months

• Gap Displacement

  12 months

Study Arms (1)

Distal Radius Fracture Patients

Adult patients who have sustained a Distal Radius Fracture.

Radiation: Low Dose CT Scan of the Wrist

Interventions

Low Dose CT Scan of the Wrist RADIATION

A low dose CT scan will be obtained in patients with a distal radius fracture of the wrist.

Distal Radius Fracture Patients

Eligibility Criteria

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

Study Population

All patients who meet above eligibility criteria who present to the Duke University Medical Center for distal radius fracture evaluation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (12)

• 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.

  PMID: 25714441 BACKGROUND

• 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.

  PMID: 3722221 BACKGROUND

• 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.

  PMID: 21981830 BACKGROUND

• 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.

  PMID: 21048172 BACKGROUND

• das Gracas 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.

  PMID: 26568720 BACKGROUND

• 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. doi: 10.1053/jhsu.2001.22930a.

  PMID: 11418901 BACKGROUND

• 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.

  PMID: 18566177 BACKGROUND

• 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.

  PMID: 19304691 BACKGROUND

• 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.

  PMID: 19332852 BACKGROUND

• 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. doi: 10.1302/0301-620X.98B12.BJJ-2016-0336.R1.

  PMID: 27909130 BACKGROUND

• 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.

  PMID: 23287769 BACKGROUND

• 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. doi: 10.1016/s0363-5023(97)80071-8.

  PMID: 9330135 BACKGROUND

MeSH Terms

Conditions

Radius Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: July 15, 2018
• Primary Completion: February 25, 2020
• Study Completion: August 25, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)