Computed Tomography for Evaluating Supination-external Ro... | NCT02599441

Studies
Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures

NCT02599441

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Oct 25, 2019Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Supination-external Rotation Ankle Fractures

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

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

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

Feb 2016

Primary Completion Date

Feb 2, 2017Actual

Completion Date

Feb 2, 2017Actual

First Submitted Date

Nov 4, 2015

First Submission Date that Met QC Criteria

Nov 5, 2015

First Posted Date

Nov 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Sep 11, 2019

Results First Submitted that Met QC Criteria

Oct 2, 2019

Results First Posted Date

Oct 25, 2019Actual

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

Oct 2, 2019

Last Update Posted Date

Oct 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Marzo, Associate Professor of Clinical Orthopaedics, 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

To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.

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

9Actual

Label	Type	Description	Intervention Names
Ankle fracture cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medial Clear Space Distance in the Ankle Joint	measured on weight bearing CBCT	Baseline- single-day study

Secondary Outcomes

Measure	Description	Time Frame
Medial Clear Space on Gravity Stress Xray		Baseline
Medial Clear Space on Standard Xray		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

willing & able to provide written informed consent
at least 18 years-old
have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray

Exclusion Criteria:

pregnant (females)
prisoners
open fracture
clinical signs of foot deformity
previous foot trauma or surgery on the affected foot
significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot
unable to stand in the weight bearing position during the CT scan

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

Patients who have been diagnosed with unstable supination-external rotation type ankle fractures

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Marzo, MD	UBMB Orthopaedics & Sports Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UBMD Orthopaedics & Sports Medicine		Buffalo	New York	14226	United States

ID	Title	Description
FG000	Ankle Fracture Cases	9 patients with SER ankle fractures

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED	Enrolled in the study	FG0009 subjects
COMPLETED	Completed the study	FG0009 subjects
NOT COMPLETED		FG0000 subjects

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Ankle Fracture Cases	9 ankle fractures included in the study

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Medial Clear Space Distance in the Ankle Joint

measured on weight bearing CBCT

Posted

Mean

Standard Deviation

Baseline- single-day study

ID	Title	Description
OG000	Ankle Fracture Cases	9 ankle fractures included in the study

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

not monitored beyond the study visit

Description

There is no risk of serious adverse events, including death, involved with this study.

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ankle Fracture Cases	9 ankle fractures included in the study	0

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Research coordinator	University at Buffalo	7162043209		mk67@buffalo.edu