OsteoarthritisNCT02552082
Scorpio Non Restricted Geometry (NRG) 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 the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship between these parameters and clinical outcomes will be evaluated as well as the importance of rotational tolerance. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Scorpio NRG posterior stabilized (PS)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2015to Mar 2018
- 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 osteoarthritis or rheumatoid arthritis.
Who may be able to join
- Patient who is candidate for primary total knee arthroplasty (TKA).
- Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.
- Patient who is age 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 risk high of a bacterial infection.
- Patient who requires revision surgery.
- 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 a 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).
- Patient who is immunologically suppressed or receiving chronic steroids.
- Patient who is judged ineligible with specific reason by primary doctor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA
The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship between these parameters and clinical outcomes will be evaluated as well as the importance of rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes and perform the same or better than other total knee implants.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Being tested
- Scorpio NRG posterior stabilized (PS)
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scorpio NRG posterior stabilized (PS)Device
| Study group | Role | What they receive |
|---|---|---|
| Scorpio NRG | Not described Receives: Device: Scorpio NRG posterior stabilized (PS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Range of motion(ROM)
Measured: Pre-operation, intraoperative, 6 months and 1 year after surgery
Secondary outcomes (2)
Change in Japanese Orthopaedics Association (JOA) score,
Measured: Pre-operation, intraoperative, 6 months and 1 year after surgery
Change in Knee Society Score (KSS)
Measured: Pre-operation, intraoperative, 6 months and 1 year after surgery
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 2018
- Study completionMar 2018
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
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Japan K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552082
- Sponsor's protocol ID
- SJCR-OR-1501
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2015
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA
- ClinicalTrials.gov ID
- NCT02552082
- Acronym / sponsor ID
- SJCR-OR-1501
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stryker Japan K.K.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- 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 the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship between these parameters and clinical outcomes will be evaluated as well as the importance of rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes and perform the same or better than other total knee implants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scorpio NRG | – | Device: Scorpio NRG posterior stabilized (PS) |
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 osteoarthritis or rheumatoid arthritis.
Key inclusion criteria (5 listed)
- Patient who is candidate for primary total knee arthroplasty (TKA).
- Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.
- Patient who is age 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 risk high of a bacterial infection.
- Patient who requires revision surgery.
- 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 a 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 |
|---|---|---|
| Scorpio NRG posterior stabilized (PS) | Device | Scorpio NRG |
Primary outcome
Change in Range of motion(ROM)
Time frame: Pre-operation, intraoperative, 6 months and 1 year after surgery
2 secondary outcomes
Change in Japanese Orthopaedics Association (JOA) score,
Time frame: Pre-operation, intraoperative, 6 months and 1 year after surgery
Change in Knee Society Score (KSS)
Time frame: Pre-operation, intraoperative, 6 months and 1 year 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 17 Sep 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, 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?
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?
Change in Range of motion(ROM) (time frame: Pre-operation, intraoperative, 6 months and 1 year after surgery). 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.