Proximal Pole Fractures of the Scaphoid

A Prospective Study of Proximal Pole Fractures of the Scaphoid

Aim:

The aim of this study is to analyze the clinical and radiological outcomes of patients with a proximal pole fracture of the scaphoid

Primary null hypothesis:

There are no factors associated with nonunion of a proximal pole fracture of the scaphoid.

Secondary null hypothesis:

Patients with an acute proximal pole fracture of the scaphoid have QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores at or above the population norm (a score of 13 in the Norway and 10.9 in the United States), 2 to 6 months after injury.

Study Overview

• Status: Withdrawn
• Conditions: Proximal Pole Fractures of the Scaphoid

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with proximal pole fracture of the scaphoid

Description

Inclusion Criteria:

• Age 18 years or greater
• Proximal pole fracture of the scaphoid on computed tomography scans made in the planes defined by the long axis of the scaphoid. The proximal pole will be defined as the proximal fifth of the scaphoid, excluding small scapholunate ligament avulsion fractures.
• Interval between injury and diagnosis of less than 2 weeks.
• English or Spanish fluency and literacy

Exclusion Criteria:

• Pregnant women
• Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
• Patients with other fractures or injuries

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Proximal Pole Fracture of the Scaphoid; QuickDASH 6 months after injury CT scan 6 months after injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability measured using QuickDASH		6 months
Nonunion of Fracture	The nonunion of the fracture will be measured using CT imaging	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Skane University Hospital; Ghaem Hospital; Medical Center Haaglanden, The Hague, The Netherlands

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2015P000177