Scorpio Non Restricted Geometry (NRG) Study in Japan
Completed
- Conditions
- OsteoarthritisRheumatoid Arthritis
- Registration Number
- NCT02552082
- Lead Sponsor
- Stryker Japan K.K.
- Brief 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. It is expected that the Scorpio NRG will have good clinical outcomes and perform the same or better than other total knee implants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Range of motion(ROM) Pre-operation, intraoperative, 6 months and 1 year after surgery
- Secondary Outcome Measures
Name Time Method Change in Knee Society Score (KSS) Pre-operation, intraoperative, 6 months and 1 year after surgery Change in Japanese Orthopaedics Association (JOA) score, Pre-operation, intraoperative, 6 months and 1 year after surgery
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms underlying mid-flexion stability in Scorpio NRG posterior stabilized implants for TKA patients with osteoarthritis and rheumatoid arthritis?
How does the rotational tolerance of Scorpio NRG compare to standard-of-care total knee implants in terms of range of motion and clinical outcomes in Japanese populations?
What biomarkers are associated with successful implant positioning and long-term effectiveness of Scorpio NRG in total knee arthroplasty for degenerative joint diseases?
What are the potential adverse events and management strategies for Scorpio NRG posterior stabilized devices in patients with rheumatoid arthritis undergoing TKA?
How do Scorpio NRG implant designs compare to other posterior stabilized total knee prostheses in addressing joint kinematics and osteoarthritis progression?
Trial Locations
- Locations (1)
Fukuoka Tokushukai Hospital.
🇯🇵Kasuga City, Fukuoka Prefecture, Japan
Fukuoka Tokushukai Hospital.🇯🇵Kasuga City, Fukuoka Prefecture, Japan