Scorpio Non Restricted Geometry (NRG) Study in Japan

The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02552082

Enrollment

150

Registered

2015-09-16

Start date

2015-06-30

Completion date

2018-03-31

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Rheumatoid Arthritis

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.

Interventions

DEVICEScorpio NRG posterior stabilized (PS)

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in Range of motion(ROM)	Pre-operation, intraoperative, 6 months and 1 year after surgery

Secondary

Measure	Time frame
Change in Japanese Orthopaedics Association (JOA) score,	Pre-operation, intraoperative, 6 months and 1 year after surgery
Change in Knee Society Score (KSS)	Pre-operation, intraoperative, 6 months and 1 year after surgery

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026