OsteoarthritisNCT00120952
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty
A study testing Bi-Metric femoral implant (titanium versus cobalt-chromium) in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Bi-Metric femoral implant (titanium versus cobalt-chromium)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento Jan 2010
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the hip
- Spinal anesthesia
- Informed written consent
Who cannot join
- Neuromuscular disease in the affected leg
- Vascular disease in the affected leg
- Fracture sequelae in the affected hip
- Weight over 100 kg
- Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.
In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.
- Conditions
- Osteoarthritis
- Being tested
- Bi-Metric femoral implant (titanium versus cobalt-chromium)
- Keywords
- RSA, Osteoarthritis, Hip arthroplasty, DEXA, Titanium, Cobalt chromium, Bone cement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-Metric femoral implant (titanium versus cobalt-chromium)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of femoral components evaluated by RSA
Secondary outcomes (1)
Periprosthetic BMD changes evaluated by DEXA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2005 (estimated)
- Study completionJan 2010
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Kjeld Søballe, MD, DMSc, Study chair, Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120952
- Sponsor's protocol ID
- M-2351-02
- Status last verified
- Dec 2022
- First submitted
- 12 Jul 2005
- Last updated
- 27 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.
- ClinicalTrials.gov ID
- NCT00120952
- Acronym / sponsor ID
- M-2351-02
- Conditions
- Osteoarthritis
- Keywords
- RSA, Osteoarthritis, Hip arthroplasty, DEXA, Titanium, Cobalt chromium, Bone cement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study completion
- Jan 2010
- First posted
- 19 Jul 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.
In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary osteoarthritis of the hip
- Spinal anesthesia
- Informed written consent
Key exclusion criteria (5 listed)
- Neuromuscular disease in the affected leg
- Vascular disease in the affected leg
- Fracture sequelae in the affected hip
- Weight over 100 kg
- Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period
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 |
|---|---|---|
| Bi-Metric femoral implant (titanium versus cobalt-chromium) | Device | – |
Primary outcome
Migration of femoral components evaluated by RSA
1 secondary outcome
Periprosthetic BMD changes evaluated by DEXA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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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.
Kjeld Søballe, MD, DMSc study chair
Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-Metric femoral implant (titanium versus cobalt-chromium) in people with Osteoarthritis, run by University of Aarhus 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 27 Dec 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Migration of femoral components evaluated by RSA. 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 27 Dec 2022.