Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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

Conditions

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Distal Tubercle Fractures of the Scaphoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fracture of Distal Tubercle of Scaphoid

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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David C. Ring, MD

Chief of Hand and Upper Extremity Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ring, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

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2014P002670

Identifier Type: -

Identifier Source: org_study_id