ReCap Total Hip Resurfacing Prospective Data Collection | NCT00758472

Studies
ReCap Total Hip Resurfacing Prospective Data Collection

NCT00758472

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Jun 19, 2017Actual

Enrollment

82Actual

Phase

Not provided

Conditions

Arthritis

Interventions

ReCap Total Hip Resurfacing

Countries

United Kingdom

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

Jun 2017

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

Mar 2005

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

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

Jun 16, 2017

Last Update Posted Date

Jun 19, 2017Actual

Name	Class
Biomet U.K. Ltd.	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

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

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hip Resurfacing			Device: ReCap Total Hip Resurfacing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ReCap Total Hip Resurfacing	Device	ReCap Total Hip Resurfacing	Hip Resurfacing

Measure	Description	Time Frame
survival rate		10 yr

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of hip joint arthritis

Exclusion criteria:

- less than 18 years of age

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 suitable for Total Hip Resurfacing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evert Smith, MD	North Bristol NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southmead Hospital		Bristol			United Kingdom
Robert Jones & Agnes Hunt Orthopaedic & District Hospital NHS Trust

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided