Articular Bearing Surface Wear of Prosthetic JointNCT00374946
A Clinical Evaluation of Wear Couples in THA
An observational study of Articular Bearing Surface Wear of Prosthetic Joint and Wear of Articular Bearing Surface of Prosthetic Joint, run by Frederiksberg University Hospital.
Trial summary
Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Articular Bearing Surface Wear of Prosthetic Joint, Wear of Articular Bearing Surface of Prosthetic Joint, Prosthesis Survival
- What is being tested?
- THA
- Type of treatment
- Medical device
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Dec 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to the orthopedic department in the inclusion period fulfilling the inclusion criteria and not having any of the exclusion criteria
Who may be able to join
- >18 Willing to participate informed consents indication for THA
Who cannot join
- <18 other diseases in the lower extremities than the actual disorder of the hip
About this study
Official title: A Randomised Controlled Clinical Study Ofbearing Surfaces in Four Hybrid Prosthesis - Results After 10 Years
Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data.
- Conditions
- Articular Bearing Surface Wear of Prosthetic Joint, Wear of Articular Bearing Surface of Prosthetic Joint, Prosthesis Survival
- Being tested
- THA
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THADevice
| Study group | Role | What they receive |
|---|---|---|
| A | THA. Bearing of Zirconia head and UHMWPE liner Receives: Device: THA | |
| B | THA. Bearing of CO-Cr-Mo head and liner Receives: Device: THA | |
| C | THA. Head og Zirconia head and UHMWPE moulded in shell (Asian) Receives: Device: THA | |
| D | THA. Head and shell og Alumina ceramic Receives: Device: THA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startDec 2000
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Bearing Surface Wear of Prosthetic JointStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Borgwardt, Frederiksberg University Hospital
- Investigators
- Arne Borgwardt, md, Principal investigator, Frederiksberg UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374946
- Sponsor's protocol ID
- KF-01-355/98
- Status last verified
- Mar 2017
- First submitted
- 11 Sep 2006
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Clinical Study Ofbearing Surfaces in Four Hybrid Prosthesis - Results After 10 Years
- ClinicalTrials.gov ID
- NCT00374946
- Acronym / sponsor ID
- KF-01-355/98
- Conditions
- Articular Bearing Surface Wear of Prosthetic Joint, Wear of Articular Bearing Surface of Prosthetic Joint, Prosthesis Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Dec 2000
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Sep 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.
Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: THATHA. Bearing of Zirconia head and UHMWPE liner |
| B | – | Device: THATHA. Bearing of CO-Cr-Mo head and liner |
| C | – | Device: THATHA. Head og Zirconia head and UHMWPE moulded in shell (Asian) |
| D | – | Device: THATHA. Head and shell og Alumina ceramic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the orthopedic department in the inclusion period fulfilling the inclusion criteria and not having any of the exclusion criteria
Key inclusion criteria (1 listed)
- >18 Willing to participate informed consents indication for THA
Key exclusion criteria (1 listed)
- <18 other diseases in the lower extremities than the actual disorder of the hip
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 |
|---|---|---|
| THA | Device | A, B, C, D |
Primary outcome
Not reported in the source record.
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 24 Mar 2017.
Related trials for Articular Bearing Surface Wear of Prosthetic Joint
RecruitingObservational study
Polyethylene Wear Particle Analysis of THA
Wear of Articular Bearing Surface of Prosthetic Joint, Hip Arthropathy
Active, not recruitingObservational study
Polyethylene Wear Particle Analysis of TKA
Wear of Articular Bearing Surface of Prosthetic Joint, Total Knee Arthroplasty
Recruiting
Migration of CS vs CR Insert in TKA Using RSA
Wear of Articular Bearing Surface of Prosthetic Joint, Migration of Implant
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.
Arne Borgwardt, md principal investigator
Frederiksberg UH
Questions about this trial
What is this clinical trial studying?
An observational study of Articular Bearing Surface Wear of Prosthetic Joint and Wear of Articular Bearing Surface of Prosthetic Joint, run by Frederiksberg University Hospital.
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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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 24 Mar 2017.