Low Dose CT Distal Radius Fractures

NCT ID: NCT03423043

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-15

Study Completion Date

2020-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radius Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Distal Radius Fracture Patients

Adult patients who have sustained a Distal Radius Fracture.

Low Dose CT Scan of the Wrist

Intervention Type RADIATION

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25714441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3722221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21981830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21048172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26568720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11418901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18566177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19304691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19332852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27909130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23287769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9330135 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00089089

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.