OsteoarthrosisNCT00192699
Bimetric-10: Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-Metric Stem
An observational study of Osteoarthrosis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
This is a 10 year follow-up investigation of patients who have underwent total hip arthroplasty with a cemented Bimetric stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthrosis
- What is being tested?
- Bimetric femoral stem
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Apr 2011
- 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: Patients with osteoarthrosis in hip who have underwent surgery for 10 years ago using Cemented Bi-Metric femoral stem.
Who may be able to join
- Osteoarthrosis
Who cannot join
- Malignancies
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, Northern Jutland, 9000
About this study
Official title: 10 Year Follow-up Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-metric Stem
This is a 10 year follow-up investigation of patients who have underwent total hip arthroplasty with a cemented Bimetric stem.
- Conditions
- Osteoarthrosis
- Being tested
- Bimetric femoral stem
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimetric femoral stemDevice
Also called Cemented Bi-Metric femoral stem
Cemented Bi-Metric femoral stem
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cemented Bi-Metric femoral stem | Cemented Bi-Metric femoral stem Receives: Device: Bimetric femoral stem |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrosisStudies 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
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mogens B Laursen, MD, PhD, Principal investigator, Northern Orthopaedic Division, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192699
- Sponsor's protocol ID
- ON-04-008b-JPE
- Status last verified
- Mar 2014
- First submitted
- 11 Sep 2005
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Year Follow-up Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-metric Stem
- ClinicalTrials.gov ID
- NCT00192699
- Acronym / sponsor ID
- ON-04-008b-JPE
- Conditions
- Osteoarthrosis
- Keywords
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Sep 2005 (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.
This is a 10 year follow-up investigation of patients who have underwent total hip arthroplasty with a cemented Bimetric stem.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cemented Bi-Metric femoral stem | – | Device: Bimetric femoral stemCemented Bi-Metric femoral stem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarthrosis in hip who have underwent surgery for 10 years ago using Cemented Bi-Metric femoral stem.
Key inclusion criteria (1 listed)
- Osteoarthrosis
Key exclusion criteria (1 listed)
- Malignancies
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 |
|---|---|---|
| Bimetric femoral stemAlso: Cemented Bi-Metric femoral stemCemented Bi-Metric femoral stem | Device | Group 1: Cemented Bi-Metric femoral stem |
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 31 Mar 2014.
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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.
Mogens B Laursen, MD, PhD principal investigator
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthrosis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 31 Mar 2014. 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 Denmark. 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.
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 31 Mar 2014.