Warwick Metal On Metal Study | NCT02262468

Studies
Warwick Metal On Metal Study

NCT02262468

Sponsor

South Warwickshire NHS Foundation Trust

Status

Completed

Last Update Posted

Oct 13, 2014Estimated

Enrollment

750Actual

Phase

Not provided

Conditions

Metal Hip Replacement

Interventions

x ray

Countries

Not provided

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 7, 2014

First Submission Date that Met QC Criteria

Oct 10, 2014

First Posted Date

Oct 13, 2014Estimated

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 10, 2014

Last Update Posted Date

Oct 13, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephen Young, consultant orthopaedic surgeon, South Warwickshire NHS Foundation TrustPrincipal Investigator

Lead Sponsor

South Warwickshire NHS Foundation TrustOTHER

Collaborators

Name	Class
DePuy International	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

assess results of metal on metal hip replacements carried out at warwick hospital

Detailed Description

Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.

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

750Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MOM total hip replacements		all patients with MOM 36mm hip replacements	Radiation: x ray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
x ray	Radiation		MOM total hip replacements

Measure	Description	Time Frame
Oxford hip score		6 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with 36mm metal on metal hips

Exclusion Criteria:

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

All patients with 36mm metal on metal hips

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided