Use of a Novel Weight Bearing Cone Beam Computed Tomograp... | NCT02762630

Studies
Use of a Novel Weight Bearing Cone Beam Computed Tomography (CBCT) Scanner for Imaging of the Patellofemoral Joint

NCT02762630

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Apr 27, 2017Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Patellofemoral Joint

Interventions

Carestream Health Inc. weight bearing cone beam CT scanner

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

Apr 2017

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

Jul 2016

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

May 3, 2016

First Submission Date that Met QC Criteria

May 4, 2016

First Posted Date

May 5, 2016Estimated

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

Apr 26, 2017

Last Update Posted Date

Apr 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Marzo, Associate Professor of Clinical Orthopedics, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

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

Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess normal alignment of the knee joint

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

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

20Actual

Name	Type	Description	Arm Group Labels	Other Names
Carestream Health Inc. weight bearing cone beam CT scanner	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tibial tubercle-trochlear groove (TT-TG) offset distance (mm)		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to provide written informed consent
Be 16 or more years of age
Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion during the images

Exclusion Criteria:

Have a history of patella instability
Have had any type of previous knee surgery
Have had a significant fracture of the patellofemoral joint
Have a knee ligament injury
Are pregnant at the time of screening or become pregnant during the study
Have a history of high radiation exposure (i.e., undergone radiation therapy)
Non-English speakers

Accepts Healthy Volunteers

Yes

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

Healthy volunteers

Sampling Method

Non-Probability Sample