Clinical trial NCT02366234: Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
Official title: Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Distal Tubercle Fractures of the Scaphoid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Haaglanden Medical Centre
name: Skane University Hospital
name: Ghaem Hospital
First posted: 2015-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with distal tubercle fracture of the scaphoid

Brief summary: AIM:

The aim of this study is to assess whether patients with an acute distal tubercle fracture of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms and disability 6 months after injury as the average for the normal population.

NULL HYPOTHESIS:

Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway and 10.9 in the United States) 6 months after injury when treated symptomatically with a removable brace.

Detailed description: Fractures of the distal scaphoid tubercle are uncommon and seem relatively benign. Not a lot is known in literature about this specific type of avulsion fracture and the treatment. Some surgeons recommend a cast for 4 to 6 weeks while others treat their patients with a removable brace. The only non-union reported in literature is Jonssen who published a case in 1990 about a non-union of a tubercle fracture in a patient with repeated trauma. Kraus et al studied 81 cases of acute scaphoid fractures and found 4 cases of tubercle avulsion fractures in this group. We suspect some patients will not seek care for this condition as it hurts for a bit and then causes no problems.

Response variables:

* Quick DASH measured 6 months after injury
* 11-point ordinal measure of overall pain intensity 6 months after trauma

Explanatory variables:

* Socio-demographics
* Age, sex, ethnicity, race, marital status, education, work status
* Questionnaires
* Quick DASH after trauma (\< 2 weeks)
* 11-point ordinal measure of overall pain intensity 6 months after trauma
* 11-point ordinal measure of satisfaction with treatment 6 months after trauma

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Fracture of the distal tubercle of the scaphoid on radiographs
* Interval between injury and diagnosis of less than 2 months
* 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

Primary outcomes:
measure: Disability with use of QuickDASH
timeFrame: 2 weeks
Secondary outcomes:
measure: Overall Pain Intensity
timeFrame: 6 months
measure: Satisfaction with Treatment
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: David Ring, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: