- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285974
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
December 6, 2022 updated by: University Hospital, Ghent
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hip osteoarthritis
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hip prosthesis
|
metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration of metal ions in the blood
Time Frame: preoperatively, and 3, 6, 12 and 24 months postoperatively.
|
preoperatively, and 3, 6, 12 and 24 months postoperatively.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2003
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
February 1, 2006
First Submitted That Met QC Criteria
February 1, 2006
First Posted (Estimate)
February 2, 2006
Study Record Updates
Last Update Posted (Estimate)
December 8, 2022
Last Update Submitted That Met QC Criteria
December 6, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003/398
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Osteoarthritis
-
Istituto Ortopedico RizzoliRecruiting
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
CHU de ReimsCompleted
-
Royan InstituteCompletedHip OsteoarthritisIran, Islamic Republic of
-
Daiichi Sankyo, Inc.TerminatedSymptomatic Hip OsteoarthritisFrance
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
Johan KarrholmCompletedPrimary Osteoarthritis of Hip Nos | Secondary Osteoarthritis of Hip
-
Lawson Health Research InstituteCompletedHip Osteoarthritis | Hip ArthroplastyCanada
Clinical Trials on metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
-
University Hospital, GhentCompletedIndications for a Total Hip ProsthesisBelgium
-
Hospices Civils de LyonMINAPATH DéveloppementRecruiting
-
Sahlgrenska University Hospital, SwedenStryker NordicUnknown
-
MicroPort Orthopedics Inc.TerminatedTotal Hip Replacement SystemUnited States
-
Istituto Ortopedico RizzoliCompletedPost-traumatic Osteoarthritis | Hip OsteoarthritisItaly
-
DePuy OrthopaedicsTerminatedOsteoarthritis | Avascular Necrosis | Post-traumatic Arthritis | Congenital Hip Dysplasia | Non-inflammatory Joint DiseaseUnited States
-
Zimmer BiometActive, not recruitingOsteoarthritisFinland, United Kingdom
-
Mansoura UniversityActive, not recruitingPartial Edentulism Class 1Egypt
-
MicroPort Orthopedics Inc.CompletedJoint Pain | Osteoarthritis, Hip | Hip Osteoarthritis | Hip DiseaseUnited States
-
Zimmer BiometActive, not recruitingOsteoarthritis | Rheumatoid Arthritis | Avascular Necrosis | Inflammatory Arthritis | Post-traumatic ArthritisUnited States