Indications for a Total Hip ProsthesisNCT00285129
Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients
A study testing ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing in people with Indications for a Total Hip Prosthesis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Comparison of the functional result and speed of rehabilitation between two types of hip prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Indications for a Total Hip Prosthesis
- What is being tested?
- ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2004to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total hip replacement
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of the functional result and speed of rehabilitation between two types of hip prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing.
- Conditions
- Indications for a Total Hip Prosthesis
- Being tested
- ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional result
Speed of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indications for a Total Hip ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Rene Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285129
- Sponsor's protocol ID
- 2004/338
- Status last verified
- Dec 2007
- First submitted
- 31 Jan 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients
- ClinicalTrials.gov ID
- NCT00285129
- Acronym / sponsor ID
- 2004/338
- Conditions
- Indications for a Total Hip Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 1 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the functional result and speed of rehabilitation between two types of hip prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total hip replacement
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing | Device | – |
Primary outcome
Functional result
Speed of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Verdonk, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing in people with Indications for a Total Hip Prosthesis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional result. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.