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

NCT ID: NCT00285974

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-11-30

Brief Summary

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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

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hip prosthesis

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hip osteoarthritis

Exclusion Criteria

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rene Verdonk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2003/398

Identifier Type: -

Identifier Source: org_study_id

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