Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

December 20, 2016 updated by: David C. Ring, MD, Massachusetts General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with distal tubercle fracture of the scaphoid

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disability with use of QuickDASH
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Pain Intensity
Time Frame: 6 months
Pain Intensity measured with an 11-point ordinal measure of overall pain intensity 6 months after trauma
6 months
Satisfaction with Treatment
Time Frame: 6 months
Satisfaction measured with an 11-point ordinal measure of satisfaction with treatment 6 months after trauma
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Skane University Hospital
Ghaem Hospital
Haaglanden Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P002670

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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