Fluoroscopy vs. Computed Tomography for Diagnosis of Displacement and Instability of Acute Scaphoid Waist Fractures

NCT02479009 | Withdrawn

• 1 other identifier: 2014P002038
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Scaphoid Waist Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  Less than 2 weeks from injury date

Interventions

Fluoroscopy DEVICE

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Women who are capable of becoming pregnant and not on birth control will be excluded due to the risk of pregnancy.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Skane University Hospital: collaborator
• Ghaem Hospital: collaborator

MeSH Terms

Interventions

Fluoroscopy

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• David Ring, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12