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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02552082 |
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Date of registration:
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10/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Scorpio Non Restricted Geometry (NRG) Study in Japan
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Scientific title:
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The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02552082 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient who is candidate for primary total knee arthroplasty (TKA).
2. Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.
3. Patient who is age 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific
Informed Patient Consent Form.
5. Patient who is willing and able to comply with postoperative scheduled evaluations.
Exclusion Criteria:
1. Patient who has a bacterial infectious disease or has a risk high of a bacterial
infection.
2. Patient who requires revision surgery.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 40.
4. Patient who is or may be pregnant female.
5. Patient who has a neuromuscular or neurosensory deficiency, which limits ability to
evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Rheumatoid Arthritis
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Intervention(s)
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Device: Scorpio NRG posterior stabilized (PS)
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Primary Outcome(s)
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Change in Range of motion(ROM)
[Time Frame: Pre-operation, intraoperative, 6 months and 1 year after surgery]
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Secondary Outcome(s)
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Change in Knee Society Score (KSS)
[Time Frame: Pre-operation, intraoperative, 6 months and 1 year after surgery]
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Change in Japanese Orthopaedics Association (JOA) score,
[Time Frame: Pre-operation, intraoperative, 6 months and 1 year after surgery]
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Secondary ID(s)
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SJCR-OR-1501
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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