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Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02366234
Enrollment
0
Registered
2015-02-19
Start date
2015-01-31
Completion date
2016-01-31
Last updated
2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Tubercle Fractures 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

Interventions

None listed

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Haaglanden Medical Centre
CollaboratorOTHER
Skane University Hospital
CollaboratorOTHER
Ghaem Hospital
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Disability with use of QuickDASH2 weeks

Secondary

MeasureTime frameDescription
Overall Pain Intensity6 monthsPain Intensity measured with an 11-point ordinal measure of overall pain intensity 6 months after trauma
Satisfaction with Treatment6 monthsSatisfaction measured with an 11-point ordinal measure of satisfaction with treatment 6 months after trauma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026