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

NCT ID: NCT02479009

Last Updated: 2016-12-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Acute Scaphoid Waist Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Fluoroscopy

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Skane University Hospital

OTHER

Sponsor Role: collaborator

Ghaem Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David C. Ring, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Ring, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2014P002038

Identifier Type: -

Identifier Source: org_study_id