Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

Withdrawn

• Conditions: Distal Tubercle Fractures of the Scaphoid

• Registration Number: NCT02366234
• Lead Sponsor: Massachusetts General Hospital

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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability with use of QuickDASH	2 weeks

Secondary Outcome Measures

Name	Time	Method
Overall Pain Intensity	6 months	Pain Intensity measured with an 11-point ordinal measure of overall pain intensity 6 months after trauma
Satisfaction with Treatment	6 months	Satisfaction measured with an 11-point ordinal measure of satisfaction with treatment 6 months after trauma