OsteoarthritisNCT00116038
A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty
A study testing Femoral implant (Versys Fiber Metal Taper®) in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Femoral implant (Versys Fiber Metal Taper®)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Jan 2007
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary arthritis in the hip.
- Patients with sufficient bone density to allow uncemented implantation of a femoral component.
- Informed patient consent in writing.
Who cannot join
- Patients with neuromuscular or vascular disease in the affected leg.
- Patients found upon operation to be unsuited for uncemented acetabulum component.
- Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
- Patients with fracture sequelae.
- Female patients of childbearing capacity.
- Hip joint dysplasia.
- Sequelae to previous hip joint disorder in childhood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty
The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.
Read the detailed description
In younger patients femoral components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed.
The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use.
Theoretically, the greater porous surface of mid-coated implants should:
- Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time
- Improve anchorage of the implant due to the higher friction coefficient
- Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores
The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.
- Conditions
- Osteoarthritis
- Being tested
- Femoral implant (Versys Fiber Metal Taper®)
- Keywords
- RSA, Osteoarthritis, Hip arthroplasty, DEXA
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral implant (Versys Fiber Metal Taper®)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)
BMD in the surrounding bone tissue of femoral components
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startJan 2004
- Primary completionJan 2007
- Study completionJan 2007
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
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus, Aarhus University Hospital, Zimmer Biomet
- Investigators
- Kjeld Søballe, MD., Prof., Principal investigator, Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116038
- Sponsor's protocol ID
- 20030192
- Status last verified
- Jul 2009
- First submitted
- 26 Jun 2005
- Last updated
- 7 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00116038
- Acronym / sponsor ID
- 20030192
- Conditions
- Osteoarthritis
- Keywords
- RSA, Osteoarthritis, Hip arthroplasty, DEXA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Kolding Sygehus, Aarhus University Hospital, Zimmer Biomet
- Study start
- Jan 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Jun 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.
The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.
Detailed description
In younger patients femoral components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed.
The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use.
Theoretically, the greater porous surface of mid-coated implants should:
- Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time
- Improve anchorage of the implant due to the higher friction coefficient
- Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores
The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary arthritis in the hip.
- Patients with sufficient bone density to allow uncemented implantation of a femoral component.
- Informed patient consent in writing.
Key exclusion criteria (7 listed)
- Patients with neuromuscular or vascular disease in the affected leg.
- Patients found upon operation to be unsuited for uncemented acetabulum component.
- Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
- Patients with fracture sequelae.
- Female patients of childbearing capacity.
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 |
|---|---|---|
| Femoral implant (Versys Fiber Metal Taper®) | Device | – |
Primary outcome
migration of femoral components evaluated by RSA
1 secondary outcome
BMD in the surrounding bone tissue of femoral components
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 7 Jul 2009.
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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., Prof. principal investigator
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 Femoral implant (Versys Fiber Metal Taper®) 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 7 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 7 Jul 2009. 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.
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 7 Jul 2009.