Fluoroscopy vs. Computed Tomography for Diagnosis of Displacement and Instability of Acute Scaphoid Waist Fractures
Primary Purpose
Acute Scaphoid Waist Fractures
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluoroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Scaphoid Waist Fractures
Eligibility Criteria
Inclusion Criteria:
- All patients (>18 years) with a radiographically visible acute (< 2 weeks since injury) scaphoid waist fracture will be included. The subject has to speak and write English or Spanish fluently to be able to provide informed consent
Exclusion Criteria:
- Pregnant women
- Women who are capable of becoming pregnant and not on birth control will be excluded due to the risk of pregnancy.
Sites / Locations
Outcomes
Primary Outcome Measures
Accuracy of Fluoroscopy
The reference standard for calculation of diagnostic performance characteristics of fluoroscopy will be displacement on CT scanning defined as follows: Displacement on CT scan defined as any angulation or translation, or greater than 1mm gap at any point in the fracture line.
Secondary Outcome Measures
Full Information
NCT ID
NCT02479009
First Posted
June 19, 2015
Last Updated
December 20, 2016
Sponsor
Massachusetts General Hospital
Collaborators
Skane University Hospital, Ghaem Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02479009
Brief Title
Fluoroscopy vs. Computed Tomography for Diagnosis of Displacement and Instability of Acute Scaphoid Waist Fractures
Official Title
Fluoroscopy vs. Computed Tomography for Diagnosis of Displacement and Instability of Acute Scaphoid Waist Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The investigator left the institution so the study was terminated.
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Skane University Hospital, Ghaem Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim:
The aim of this study is to analyze if fluoroscopy is as accurate as computed tomography in diagnosing displacement of acute scaphoid waist fractures.
Primary null hypothesis:
Fluoroscopy has comparable sensitivity, specificity, accuracy, positive and negative predictive values compared with computed tomography for the diagnosis of displacement of acute scaphoid waist fractures.
Secondary null hypothesis:
All fractures diagnosed as non-displaced and treated without surgery are healed on radiographs and discharged from care within 6 months of injury.
Detailed Description
The only confirmed risk factor for nonunion of a scaphoid waist fracture is displacement. There is consensus that displaced fractures should be treated with open or arthroscopically assisted reduction and internal fixation (ORIF). However, the optimal method to diagnose displacement is debated. Radiographic, computed tomography (CT), and arthroscopic diagnostic criteria for the diagnosis of displacement exist. There is no consensus regarding the imaging modality and measurements to use to diagnose scaphoid displacement. The definition of displacement in recent randomized trials is incompletely described and inconsistent. Fluoroscopy is more convenient, less expensive, and uses less radiation than CT scanning. If displaced fractures are unstable, then this should be apparent on fluoroscopy. The aim of this study is to analyze if fluoroscopy is as accurate as computed tomography in diagnosing displacement of acute scaphoid waist fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Scaphoid Waist Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Fluoroscopy
Intervention Description
Each patient will undergo fluoroscopy-imaging evaluation in the office to determine whether the fracture moves (instability). The investigators will deviate the wrist from ulnar to radial and back in posteroanterior, oblique and lateral views with the wrist in neutral flexion. Any angulation or translation at the fracture site or more than one millimeter displacement or gap will be considered as a sign of instability. The fluoroscopy will be viewed and an image showing the largest gap will be saved. The diagnosis of instability (which is the same as displacement with this test) will be made by consensus of the research team.
Primary Outcome Measure Information:
Title
Accuracy of Fluoroscopy
Description
The reference standard for calculation of diagnostic performance characteristics of fluoroscopy will be displacement on CT scanning defined as follows: Displacement on CT scan defined as any angulation or translation, or greater than 1mm gap at any point in the fracture line.
Time Frame
Less than 2 weeks from injury date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients (>18 years) with a radiographically visible acute (< 2 weeks since injury) scaphoid waist fracture will be included. The subject has to speak and write English or Spanish fluently to be able to provide informed consent
Exclusion Criteria:
Pregnant women
Women who are capable of becoming pregnant and not on birth control will be excluded due to the risk of pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Fluoroscopy vs. Computed Tomography for Diagnosis of Displacement and Instability of Acute Scaphoid Waist Fractures
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