NCT02366234

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

February 6, 2015

Last Update Submit

December 20, 2016

Conditions

Distal Tubercle Fractures of the Scaphoid

Outcome Measures

Primary Outcomes (1)

  • Disability with use of QuickDASH

    2 weeks

Secondary Outcomes (2)

  • Overall Pain Intensity

    6 months

  • Satisfaction with Treatment

    6 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with distal tubercle fracture of the scaphoid

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • David Ring, MD PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Hand and Upper Extremity Service

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 19, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 22, 2016

Record last verified: 2016-12