iCORE: Collaborative Orthopedics Outcomes Registry | NCT02422667

Studies
iCORE: Collaborative Orthopedics Outcomes Registry

NCT02422667

Sponsor

SCRI Development Innovations, LLC

Status

Withdrawn

Last Update Posted

Dec 5, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee

Interventions

Patient Registry

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study cancelled - no results

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Apr 14, 2015

First Submission Date that Met QC Criteria

Apr 16, 2015

First Posted Date

Apr 21, 2015Estimated

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

Dec 1, 2023

Last Update Posted Date

Dec 5, 2023Actual

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 goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering.

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

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Patient Registry	Other	Orthopedic Data Registry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality Improvement		10 years
Treatment Patterns		5 years
Healthcare Utilization		5 years

Secondary Outcomes

Measure	Description	Time Frame
Humanistic Outcomes		10 years
Economic Outcomes		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Patients requested to be seen by an orthopedic surgeon participating in the iCORE Registry.
Patient must have the ability to understand the nature of the registry and give written informed consent.

Exclusion Criteria:

There are no exclusion criteria for this Outcomes Registry.

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 18 years and older who undergo hip and/or knee arthroplasty. Patient must have the ability to understand the nature of the registry and give written informed consent.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David K DeBoer, MD	SJRI/SCRI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SCRI		Nashville	Tennessee	37203	United States