Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-27 @ 12:22 PM
Study NCT ID:
NCT02366234
Status:
WITHDRAWN
Last Update Posted:
2016-12-22
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
Status:
WITHDRAWN
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The investigator left the institution so the study was terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: