Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

Distal Tubercle Fractures of the Scaphoid Clinical Trial

Official title:

Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02366234
• Other study ID #: 2014P002670
• Status: Withdrawn
• Phase: N/A
• First received: February 6, 2015
• Last updated: December 20, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• 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

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

• 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Distal Tubercle Fractures of the Scaphoid
• Fractures, Bone

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Ghaem Hospital, Medical Centre Haaglanden, The Hague, The Netherlands, Skane University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability with use of QuickDASH		2 weeks	No
Secondary	Overall Pain Intensity	Pain Intensity measured with an 11-point ordinal measure of overall pain intensity 6 months after trauma	6 months	No
Secondary	Satisfaction with Treatment	Satisfaction measured with an 11-point ordinal measure of satisfaction with treatment 6 months after trauma	6 months	No