NCT01660490

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

August 6, 2012

Last Update Submit

March 18, 2014

Conditions

Proximal Femur Fractures

Keywords

Radiographic Image Enhancement,Intraoperative CareFemoral FracturesFemoral Neck FracturesHip Fractures, Internal FixatorsFracture Fixation InternalFracture Fixation IntramedullaryFractures Bone

Outcome Measures

Primary Outcomes (1)

  • Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.

    Intraoperatively

Study Arms (1)

Proximal femur fractures with ORIF

Proximal femur fractures treated with ORIF

Procedure: ORIF

Interventions

ORIFPROCEDURE

Open reduction internal fixation of the proximal femur

Proximal femur fractures with ORIF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Prof. Michael Blauth

Innsbruck, Tyrol, 6020, Austria

Location

Universitätsspital Basel

Basel, Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Proximal Femoral FracturesFemoral FracturesFemoral Neck FracturesHip FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Michael Blauth, Professor

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

AU(1)CH(1)US(1)