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Clinical Trials/NCT02398942
NCT02398942
Withdrawn
Not Applicable

A Prospective Study of Proximal Pole Fractures of the Scaphoid

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Pole Fractures of the Scaphoid
Sponsor
Massachusetts General Hospital
Primary Endpoint
Disability measured using QuickDASH
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
January 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David C. Ring, MD

Chief of Orthopaedic Hand and Upper Extremity Service

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Disability measured using QuickDASH

Time Frame: 6 months

Nonunion of Fracture

Time Frame: 6 months

The nonunion of the fracture will be measured using CT imaging

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