CONSERVE Plus Post-Approval Study (PAS) | NCT01367899

Studies
CONSERVE Plus Post-Approval Study (PAS)

NCT01367899

Sponsor

MicroPort Orthopedics Inc.

Status

Terminated

Last Update Posted

Oct 28, 2014Estimated

Enrollment

199Actual

Phase

Not provided

Conditions

Other and Unspecified Injury to Hip and Thigh

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

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

Oct 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

May 2, 2011

First Submission Date that Met QC Criteria

Jun 3, 2011

First Posted Date

Jun 7, 2011Estimated

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

Oct 24, 2014

Last Update Posted Date

Oct 28, 2014Estimated

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 objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.

Detailed Description

This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study

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

No data available

No data is available for this block.

Enrollment

199Actual

Label	Type	Description	Intervention Names
CONSERVE® Plus hip resurfacing		Recipients/C Plus (IDE)study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical success at Month 120	Clinical success at Month 120 for each patient will be survivorship, defined as freedom from revision or removal for any aseptic reason and at least "good" function/pain relief defined as Harris Hip Score ≥ 80.	10 years

Secondary Outcomes

Measure	Description	Time Frame
Radiographic outcomes	Secondary measures: radiographic outcomes	10 years
Metal Ion (serum)	metal ion (serum) and renal function will also be collected.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited Cohort (N=1366 procedures (1206 patients)) and received the "Original Shell".
Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

Patient is mentally incompetent.
Patient is a prisoner.
Patient is an alcohol and/or drug abuser
Patient has undergone device revision or removal

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 already undergone hip resurfacing in the CONSERVE Plus IDE.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Bolognesi, MD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michael Bolognesi, MD		Durham	North Carolina	27705	United States