OsteoarthritisPhase 4NCT01336595
Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components
A Phase 4 study testing Zirconium (Zirconium Genesis II) and Cobalt-Chrome (Cobalt Chrome Genesis II) in people with Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Zirconium (Zirconium Genesis II) and Cobalt-Chrome (Cobalt Chrome Genesis II)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2003to Apr 2011
- Phase
- Phase 4
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Who cannot join
- Inflammatory disease
- patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components in the Same Patients: A Prospective, Double Blinded, and Randomized Controlled Study
The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.
Read the detailed description
Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.
- Conditions
- Osteoarthritis
- Being tested
- Zirconium (Zirconium Genesis II), Cobalt-Chrome (Cobalt Chrome Genesis II)
- Keywords
- total knee arthroplasty, oxidized zirconium, genesis II, femoral component, cobalt chrome
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium (Zirconium Genesis II)Device
Also called Zirconium Genesis II
Oxidized Zirconium femoral component of Genesis II TKR system is used.
Cobalt-Chrome (Cobalt Chrome Genesis II)Device
Also called Cobalt Chrome Genesis II
Cobalt Chrome Femoral Component of Genesis II TKR system is used
| Study group | Role | What they receive |
|---|---|---|
| Zirconium Femoral Component | Experimental | Oxidized zirconium femoral component of Genesis II TKR system is used. Receives: Device: Zirconium (Zirconium Genesis II) |
| Cobalt Chrome | Active comparator | Cobalt-Chromium Femoral component of Genesis II system is used. Receives: Device: Cobalt-Chrome (Cobalt Chrome Genesis II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Knee Society Knee Score
change in knee score will be compared with initial score, until mean follow up of 20 years.
Measured: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Secondary outcomes (1)
Improvement in the range of motion
change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 20 years.
Measured: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJan 2003
- Primary completionMar 2004
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hoo Kim, Ewha Womans University
- Investigators
- Jang-Won Park, MD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336595
- Sponsor's protocol ID
- TKRzirconium
- Status last verified
- Oct 2011
- First submitted
- 14 Apr 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ezzet KA, Hermida JC, Colwell CW Jr, D'Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res. 2004 Nov;(428):120-4. doi: 10.1097/01.blo.0000148576.70780.13.
PubMed 15534531Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D. Reduced wear with oxidized zirconium femoral heads. J Bone Joint Surg Am. 2003;85-A Suppl 4:105-10. doi: 10.2106/00004623-200300004-00013. No abstract available.
PubMed 14652400
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components in the Same Patients: A Prospective, Double Blinded, and Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01336595
- Acronym / sponsor ID
- TKRzirconium
- Conditions
- Osteoarthritis
- Keywords
- total knee arthroplasty, oxidized zirconium, genesis II, femoral component, cobalt chrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Apr 2011 (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 determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.
Detailed description
Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconium Femoral Component | Experimental | Device: Zirconium (Zirconium Genesis II)Oxidized zirconium femoral component of Genesis II TKR system is used. |
| Cobalt Chrome | Active comparator | Device: Cobalt-Chrome (Cobalt Chrome Genesis II)Cobalt-Chromium Femoral component of Genesis II system is used. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Key exclusion criteria (5 listed)
- Inflammatory disease
- patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
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 |
|---|---|---|
| Zirconium (Zirconium Genesis II)Also: Zirconium Genesis IIOxidized Zirconium femoral component of Genesis II TKR system is used. | Device | Zirconium Femoral Component |
| Cobalt-Chrome (Cobalt Chrome Genesis II)Also: Cobalt Chrome Genesis IICobalt Chrome Femoral Component of Genesis II TKR system is used | Device | Cobalt Chrome |
Primary outcome
Improvement in Knee Society Knee Score
Time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
change in knee score will be compared with initial score, until mean follow up of 20 years.
1 secondary outcome
Improvement in the range of motion
Time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
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 5 Oct 2011.
- Background: PubMed 15534531Ezzet KA, Hermida JC, Colwell CW Jr, D'Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res. 2004 Nov;(428):120-4. doi: 10.1097/01.blo.0000148576.70780.13.
- Background: PubMed 14652400Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D. Reduced wear with oxidized zirconium femoral heads. J Bone Joint Surg Am. 2003;85-A Suppl 4:105-10. doi: 10.2106/00004623-200300004-00013. No abstract available.
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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.
Jang-Won Park, MD principal investigator
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zirconium (Zirconium Genesis II) and Cobalt-Chrome (Cobalt Chrome Genesis II) in people with Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
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 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 5 Oct 2011. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement in Knee Society Knee Score (time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery). 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 NCT01336595, which also lists 2 linked publications.
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 5 Oct 2011.