Scorpio Non Restricted Geometry (NRG) Study in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Scorpio NRG

Scorpio NRG posterior stabilized (PS)

Intervention Type DEVICE

Interventions

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Scorpio NRG posterior stabilized (PS)

Intervention Type DEVICE

Eligibility 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No