Dosage of Metal Ions in the Blood of Different Metal-on-m... | NCT00285974

Studies
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity

NCT00285974

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 8, 2022Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Hip Osteoarthritis

Interventions

metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis

Countries

Belgium

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

Dec 2022

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 2003Actual

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Feb 1, 2006

First Submission Date that Met QC Criteria

Feb 1, 2006

First Posted Date

Feb 2, 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

Dec 6, 2022

Last Update Posted Date

Dec 8, 2022Actual

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

Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hip prosthesis	Experimental		Device: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis	Device	metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis	hip prosthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of metal ions in the blood		preoperatively, and 3, 6, 12 and 24 months postoperatively.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hip osteoarthritis

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rene Verdonk, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided