OsteoarthritisNCT02552069
Tritanium® Study in Japan
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Stryker Japan K.K. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate early fixation and stability of the Tritanium cup. It is expected that the Tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of Japanese surgeons. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis of the Femoral Head
- What is being tested?
- Tritanium® cup
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2015to Mar 2020
- How long will I take part?
- 2 Years
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis
Who may be able to join
- Patient is a candidate for a primary Total Hip Arthroplasty (THA).
- Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis.
- Patient whose age is 20 or over.
- Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
- Patient who is willing and able to comply with postoperative scheduled evaluations.
Who cannot join
- Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
- Patient who requires revision surgery of a previously implanted total hip arthroplasty.
- Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 40.
- Patient who is or may be pregnant female.
- Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy), which limits ability to evaluate the safety and efficacy of the device.
- Patient who is immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device.
- Patients who is judged ineligible with specific reason by primary doctor.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
RINKU General Medical Center
Izumisano, Osaka, 598-8577
+81-72 - 469 - 3111
About this study
Official title: The Verification Study on the Early Fixation/ Stability of Tritanium Cup
The purpose of this study is to evaluate early fixation and stability of the Tritanium cup. It is expected that the Tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.
- Being tested
- Tritanium® cup
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tritanium® cupDevice
| Study group | Role | What they receive |
|---|---|---|
| Tritanium® cup | Not described Receives: Device: Tritanium® cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implantation position(angle) of the cup
Measured: Baseline, intraoperative, 3 months, 6 months and 12 months
Secondary outcomes (2)
Change in Japanese Orthopaedic Association (JOA) score
Measured: Baseline, 3 months, 6months and 12 months
Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D)
Measured: Pre-operation, 3 months, 6months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
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.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Stryker Japan K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasuyuki Inatsugu, Study director, Stryker Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552069
- Sponsor's protocol ID
- SJCR-OR-1505
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2015
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Verification Study on the Early Fixation/ Stability of Tritanium Cup
- ClinicalTrials.gov ID
- NCT02552069
- Acronym / sponsor ID
- SJCR-OR-1505
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stryker Japan K.K.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 16 Sep 2015 (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 evaluate early fixation and stability of the Tritanium cup. It is expected that the Tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tritanium® cup | – | Device: Tritanium® cup |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis
Key inclusion criteria (5 listed)
- Patient is a candidate for a primary Total Hip Arthroplasty (THA).
- Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis.
- Patient whose age is 20 or over.
- Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
- Patient who is willing and able to comply with postoperative scheduled evaluations.
Key exclusion criteria (8 listed)
- Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
- Patient who requires revision surgery of a previously implanted total hip arthroplasty.
- Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 40.
- Patient who is or may be pregnant female.
- Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
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 |
|---|---|---|
| Tritanium® cup | Device | Tritanium® cup |
Primary outcome
Change in implantation position(angle) of the cup
Time frame: Baseline, intraoperative, 3 months, 6 months and 12 months
2 secondary outcomes
Change in Japanese Orthopaedic Association (JOA) score
Time frame: Baseline, 3 months, 6months and 12 months
Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D)
Time frame: Pre-operation, 3 months, 6months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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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.
Yasuyuki Inatsugu study director
Stryker Japan
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 Osteoarthritis and Rheumatoid Arthritis, run by Stryker Japan K.K. at 1 site in Japan.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Sep 2018. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ysuyuki Inatsugu (+81-3-6894-8394, yasuyuki.inatsugu@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in implantation position(angle) of the cup (time frame: Baseline, intraoperative, 3 months, 6 months and 12 months). 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 17 Sep 2018.