Development and Validation of Intraoperative Image-qualit... | NCT01660490

Studies
Development and Validation of Intraoperative Image-quality Criteria

NCT01660490

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Completed

Last Update Posted

Mar 19, 2014Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Proximal Femur Fractures

Interventions

ORIF

Countries

United States
Austria
Switzerland

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 6, 2012

First Submission Date that Met QC Criteria

Aug 6, 2012

First Posted Date

Aug 8, 2012Estimated

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

Mar 18, 2014

Last Update Posted Date

Mar 19, 2014Estimated

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

An expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons.

The panel is set to initiate a consensus-based evaluation process to develop a list of criteria for assessing images and would like to validate these criteria for differentiating good quality versus poor quality images in term of reliability and accuracy.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proximal femur fractures with ORIF		Proximal femur fractures treated with ORIF	Procedure: ORIF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ORIF	Procedure	Open reduction internal fixation of the proximal femur	Proximal femur fractures with ORIF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.		Intraoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of proximal femur fracture
Operated between May 2010 and December 2010
Open Reduction Internal Fixation (ORIF)
Lateral and anteroposterior intraoperative images available

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with a proximal femur fractures treated with ORIF between May 2010 and December 2010

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Blauth, Professor	Medical University Innsbruck	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States
Prof. Michael Blauth

Condition Browse Module

MeSH Terms

ID	Term
D000092526	Proximal Femoral Fractures
D005264	Femoral Fractures
D005265	Femoral Neck Fractures
D006620	Hip Fractures
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided