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

Primary Purpose

Hip Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hip osteoarthritis Exclusion Criteria: -

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hip prosthesis

Arm Description

Outcomes

Primary Outcome Measures

Concentration of metal ions in the blood

Secondary Outcome Measures

Full Information

NCT ID

NCT00285974

First Posted

February 1, 2006

Last Updated

December 6, 2022

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00285974

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

December 2003 (Actual)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hip prosthesis

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Concentration of metal ions in the blood

Time Frame

preoperatively, and 3, 6, 12 and 24 months postoperatively.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hip osteoarthritis Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rene Verdonk, MD, PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Learn more about this trial

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

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