Symptomatic Treatment of Distal Tubercle Fractures of the... | NCT02366234

Studies
Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid

NCT02366234

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Dec 22, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Distal Tubercle Fractures of the Scaphoid

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigator left the institution so the study was terminated.

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 6, 2015

First Submission Date that Met QC Criteria

Feb 11, 2015

First Posted Date

Feb 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2016

Last Update Posted Date

Dec 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David C. Ring, MD, Chief of Hand and Upper Extremity Service, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disability with use of QuickDASH		2 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with distal tubercle fracture of the scaphoid

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Ring, MD PhD	Massachusetts General Hospital	Principal Investigator

Locations

Not provided