Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects | NCT00721994

Studies
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects

NCT00721994

Sponsor

Corin

Status

Completed

Last Update Posted

Nov 21, 2018Actual

Enrollment

231Actual

Phase

Not provided

Conditions

Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis

Interventions

Cormet Hip Resurfacing System

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

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

May 2008

Primary Completion Date

Jun 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 25, 2008Estimated

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

Nov 20, 2018

Last Update Posted Date

Nov 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.

Detailed Description

Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.

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

Retention

Enrollment

231Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		IDE subjects who received the Cormet Hip Resurfacing device	Device: Cormet Hip Resurfacing System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cormet Hip Resurfacing System	Device	Cormet Hip Resurfacing System	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval		10 years

Secondary Outcomes

Measure	Description	Time Frame
Harris Hip Score components including total score, pain, function and range of motion		10 years
device survival		10 years
device related adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
Individuals who agree to participate in the study by signing the informed patient consent form

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

IDE study subjects at 5 IDE study sites

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathy Trier, Ph.D.	Corin	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Space Coast Orthopaedics Ctr.		Merritt Island	Florida	32953	United States
Kennedy White Orthopedics

Type	Date	Date Unknown
Release	Aug 10, 2021
Reset	Sep 3, 2021

Submission Tracking

Estimated Results First Submitted Date

Aug 10, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 10, 2021			Sep 3, 2021

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D010020	Osteonecrosis
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided