Data Collection on ReCap/Magnum in Total Hip Replacement... | NCT00758355

Studies
Data Collection on ReCap/Magnum in Total Hip Replacement and Resurfacing

NCT00758355

Sponsor

Zimmer Biomet

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Total Hip Resurfacing

Interventions

Not provided

Countries

France

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

Jan 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

Mar 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Jun 2016Actual

First Submitted Date

Sep 23, 2008

First Submission Date that Met QC Criteria

Sep 23, 2008

First Posted Date

Sep 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

Feb 21, 2017

Last Update Posted Date

Feb 23, 2017Actual

Name	Class
Biomet France SARL	INDUSTRY

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

Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Detailed Description

This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
M2A magnum		Consecutive series of patients received Total Hip Resurfacing with ReCap/Magnum
Recap Magnum		Consecutive series of patients received Total Hip Replacement with ReCap/Magnum

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postel-Merle d'Aubigné (PMA), Harris Hip Score		1yr and 2yr

Secondary Outcomes

Measure	Description	Time Frame
Complication		Any time
Survival		1yr and 2yr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Its Respective Indications for Use/Intended Uses

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

Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Their Respective Indications for Use/Intended Uses

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique Saragaglia, Pr	Hopital Sud - Echirolles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens		Amiens		80000	France
CHU Pellegrin Tripode