Operative Versus Nonoperative Treatment for Scapula Fract... | NCT00849771

Studies
Operative Versus Nonoperative Treatment for Scapula Fractures

NCT00849771

Sponsor

Vanderbilt University

Status

Withdrawn

Last Update Posted

Nov 13, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Scapula Fracture
Clavicle Fracture

Interventions

Not provided

Countries

United States

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Joined another larger group of same study

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Feb 20, 2009

First Submission Date that Met QC Criteria

Feb 23, 2009

First Posted Date

Feb 24, 2009Estimated

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

Nov 10, 2015

Last Update Posted Date

Nov 13, 2015Estimated

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

The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.

The potential impact is a clearer set of choices in treatment options for this type of injury.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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
1		Operative Treatment (Open Reduction Internal Fixation)
2		Non-operative/Conservative Care

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 Years of Age or Older
Displacement of glenoid neck and scapula body of greater than 2 cm
Angular deformity between the fracture fragments of greater than 45 degrees.
A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees
A glenopolar angle less than 22 degrees
A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC)

Exclusion Criteria:

Age Less Than 18 years Old
Brachial Plexus Injury
Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation
Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage
Ipsilateral Upper Extremity Injury
Previous Shoulder Surgery
Insufficient English proficiency to complete the DASH Questionnaire

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

The subject population will include patients seen at participating facilities for the care of scapula fractures, who are 18 years of age or older, meet inclusion/exclusion criteria and are willing to consent.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William T. Obremskey, MD, MPH	Vanderbilt University Medical Center	Principal Investigator
Peter Cole, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center		Nashville	Tennessee	37232-8774	United States