A Clinical Evaluation of Wear Couples in THA | NCT00374946

Studies
A Clinical Evaluation of Wear Couples in THA

NCT00374946

Sponsor

Frederiksberg University Hospital

Status

Completed

Last Update Posted

Mar 24, 2017Actual

Enrollment

392Actual

Phase

Not provided

Conditions

Articular Bearing Surface Wear of Prosthetic Joint
Wear of Articular Bearing Surface of Prosthetic Joint
Prosthesis Survival

Interventions

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

Mar 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

Dec 2000

Primary Completion Date

Jan 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Sep 11, 2006

First Submission Date that Met QC Criteria

Sep 11, 2006

First Posted Date

Sep 12, 2006Estimated

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

Mar 22, 2017

Last Update Posted Date

Mar 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arne Borgwardt, MD Head of Department, Frederiksberg University HospitalPrincipal Investigator

Lead Sponsor

Frederiksberg University HospitalOTHER

Collaborators

Not provided

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

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

392Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
A	THA. Bearing of Zirconia head and UHMWPE liner	Device: THA
B	THA. Bearing of CO-Cr-Mo head and liner	Device: THA
C	THA. Head og Zirconia head and UHMWPE moulded in shell (Asian)	Device: THA
D	THA. Head and shell og Alumina ceramic	Device: THA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
THA	Device		A B C D

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 Willing to participate informed consents indication for THA

Exclusion Criteria:

<18 other diseases in the lower extremities than the actual disorder of the hip

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

All patients referred to the orthopedic department in the inclusion period fulfilling the inclusion criteria and not having any of the exclusion criteria

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Arne Borgwardt, md	Frederiksberg UH	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D011475	Prosthesis Failure

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided