OsteoarthritisNCT00380549
A Comparison of an Advanced Metal Hip System to a Resurfacing Hip System
A study testing Blood ion levels in people with Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Blood ion levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Individuals undergoing unilateral total hip replacement with the CONSERVE® acetabular component and the CONSERVE® A-Class BFHä femoral head in combination with an uncemented femoral stem produced from the Ti-6A1-4V alloy (ASTM F-136) with or without titanium plasma coating.
- Patients who are undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD). Composite diagnoses of NIDJD include osteo/degenerative arthritis, traumatic arthritis, congenital hip dysplasia, and avascular necrosis.
- Patients 18 years of age or older (skeletally mature). (4) Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period and for annual exams until the last patient entered into the study has achieved two years of follow-up.
- Patients who agree to participate and sign the Informed Consent Form. (6) Patients who do not meet any of the exclusion criteria.
Who cannot join
- (1) Patients with previous fusions, acute femoral neck fractures, above knee amputations, or significant arthritic changes to the knees.
- Patients with evidence of active infection. (3) Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.
- Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device.
- Patients with neuropathic joints. (6) Patients with severe documented psychiatric disease. (7) Patients requiring structural bone grafts. (8) Patients with a documented allergy to cobalt chromium molybdenum. (9) Patients with an ipsilateral girdlestone. (10) Patients with sickle cell disease. (11) Patients with renal failure as defined by serum creatinine level greater than 180 Fmol/L.
- Patients who otherwise meet the study criteria, but refuse to consent in writing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Case Series (Pilot Study) Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Type Hip System With BFH™ Technology to the CONSERVE® Plus Total Hip Resurfacing System
The primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes between patients who receive the CONSERVE® A-Class Total Hip compared to those who have received the CONSERVE® Plus Total Resurfacing Hip System.
Read the detailed description
A standard hip replacement involves replacing your hip joint with several parts: the cup which forms the socket in the pelvis; a head that forms a new ball for the top of the thigh bone; and a stem which is placed into the thigh bone. Typically, the socket is made out of metal and plastic, and the ball and stem are made out of metal.
Recently, new metal-on-metal hip replacement systems have been developed where both the socket and the shell are made out of metal. This can cause metal ions to be released into the body. The CONSERVE® A-Class Total Hip with BFH technology is a new metal-on-metal total hip system which utilizes a large diameter femoral head (36-54 mm) more similar to the size of the original head (i.e., your original bone). Further, this system utilizes an advanced metal design which wears at a slower rate than typical metal-on-metal implants. Therefore, the primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes between patients who receive the CONSERVE® A-Class Total Hip compared to those who have received the CONSERVE® Plus Total Resurfacing Hip System.
- Conditions
- Osteoarthritis
- Being tested
- Blood ion levels
- Keywords
- osteoarthritis, hip replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ion levelsDiagnostic test
Blood ion levels or the levels of cobalt and chromium ions in the blood and urine will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| CONSERVE® A-Class THA BFH | Active comparator | CONSERVE® A-Class Total Hip with BFH technology. Patients in this arm will undergo a unilateral total hip replacement with the CONSERVE® acetabular component and the CONSERVE® A-Class BFH femoral head. Blood ion levels will be collected and analyzed. Receives: Diagnostic Test: Blood ion levels |
| CONSERVE® Plus Total Resurfacing Hip System | Active comparator | CONSERVE® Plus Total Resurfacing Hip System. Patients in this arm will undergo a unilateral total hip replacement with the CONSERVE® Plus Total Resurfacing Hip System. Blood ion levels will be collected and analyzed. Receives: Diagnostic Test: Blood ion levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood ion levels
Assessment of Chromium and Cobalt ion levels in the blood
Measured: 2 years post-operative
Secondary outcomes (1)
functional outcomes radiographic outcomes complication rates
Assessment of clinical efficiency of the implant by validated questionannires and radiographic analysis
Measured: 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Responsible party
- Sponsor
- Investigators
- Paul Kim, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380549
- Sponsor's protocol ID
- OHREB 2005884-01H
- Status last verified
- Mar 2020
- First submitted
- 23 Sep 2006
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beaule PE, Kim PR, Hamdi A, Fazekas A. A prospective metal ion study of large-head metal-on-metal bearing: a matched-pair analysis of hip resurfacing versus total hip replacement. Orthop Clin North Am. 2011 Apr;42(2):251-7, ix. doi: 10.1016/j.ocl.2011.01.005.
PubMed 21435499
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Series (Pilot Study) Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Type Hip System With BFH™ Technology to the CONSERVE® Plus Total Hip Resurfacing System
- ClinicalTrials.gov ID
- NCT00380549
- Acronym / sponsor ID
- OHREB 2005884-01H
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, hip replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Study start
- Jun 2006 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 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.
The primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes between patients who receive the CONSERVE® A-Class Total Hip compared to those who have received the CONSERVE® Plus Total Resurfacing Hip System.
Detailed description
A standard hip replacement involves replacing your hip joint with several parts: the cup which forms the socket in the pelvis; a head that forms a new ball for the top of the thigh bone; and a stem which is placed into the thigh bone. Typically, the socket is made out of metal and plastic, and the ball and stem are made out of metal.
Recently, new metal-on-metal hip replacement systems have been developed where both the socket and the shell are made out of metal. This can cause metal ions to be released into the body. The CONSERVE® A-Class Total Hip with BFH technology is a new metal-on-metal total hip system which utilizes a large diameter femoral head (36-54 mm) more similar to the size of the original head (i.e., your original bone). Further, this system utilizes an advanced metal design which wears at a slower rate than typical metal-on-metal implants. Therefore, the primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes between patients who receive the CONSERVE® A-Class Total Hip compared to those who have received the CONSERVE® Plus Total Resurfacing Hip System.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONSERVE® A-Class THA BFH | Active comparator | Diagnostic Test: Blood ion levelsCONSERVE® A-Class Total Hip with BFH technology. Patients in this arm will undergo a unilateral total hip replacement with the CONSERVE® acetabular component and the CONSERVE® A-Class BFH femoral head. Blood ion levels will be collected and analyzed. |
| CONSERVE® Plus Total Resurfacing Hip System | Active comparator | Diagnostic Test: Blood ion levelsCONSERVE® Plus Total Resurfacing Hip System. Patients in this arm will undergo a unilateral total hip replacement with the CONSERVE® Plus Total Resurfacing Hip System. Blood ion levels will be collected and analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) Individuals undergoing unilateral total hip replacement with the CONSERVE® acetabular component and the CONSERVE® A-Class BFHä femoral head in combination with an uncemented femoral stem produced from the Ti-6A1-4V alloy (ASTM F-136) with or without titanium plasma coating.
Key exclusion criteria (5 listed)
- (1) Patients with previous fusions, acute femoral neck fractures, above knee amputations, or significant arthritic changes to the knees.
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 |
|---|---|---|
| Blood ion levelsBlood ion levels or the levels of cobalt and chromium ions in the blood and urine will be analyzed. | Diagnostic test | CONSERVE® A-Class THA BFH, CONSERVE® Plus Total Resurfacing Hip System |
Primary outcome
blood ion levels
Time frame: 2 years post-operative
Assessment of Chromium and Cobalt ion levels in the blood
1 secondary outcome
functional outcomes radiographic outcomes complication rates
Time frame: 2 years post-operatively
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 10 Mar 2020.
- Results publication: PubMed 21435499Beaule PE, Kim PR, Hamdi A, Fazekas A. A prospective metal ion study of large-head metal-on-metal bearing: a matched-pair analysis of hip resurfacing versus total hip replacement. Orthop Clin North Am. 2011 Apr;42(2):251-7, ix. doi: 10.1016/j.ocl.2011.01.005.
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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.
Paul Kim, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood ion levels in people with Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 10 Mar 2020. 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 Canada. 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?
blood ion levels (time frame: 2 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00380549, which also lists 1 linked publication.
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 10 Mar 2020.