Proximal Pole Fractures of the Scaphoid Clinical Trial
Official title:
A Prospective Study of Proximal Pole Fractures of the Scaphoid
| Verified date | December 2016 |
| Source | Massachusetts General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Ghaem Hospital, Medical Center Haaglanden, The Hague, The Netherlands, Skane University Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disability measured using QuickDASH | 6 months | No | |
| Primary | Nonunion of Fracture | The nonunion of the fracture will be measured using CT imaging | 6 months | No |