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CompletedNCT02552082Updated Sep 17, 2018

Scorpio Non Restricted Geometry (NRG) Study in Japan

An observational study in Osteoarthritis and Rheumatoid Arthritis, sponsored by Stryker Japan K.K.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-09-17.

Sponsored by Stryker Japan K.K. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
20 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Osteoarthritis
  • Rheumatoid Arthritis

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03

In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 150 is above the median of 100 across 790 observational studies indexed under Osteoarthritis.

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Lead sponsor

Stryker Japan K.K. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Scorpio NRG

    Device: Scorpio NRG posterior stabilized (PS)

Interventions

  • DeviceScorpio NRG posterior stabilized (PS)
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What researchers measure

Primary outcomes

  1. Change in Range of motion(ROM)

    Time frame: Pre-operation, intraoperative, 6 months and 1 year after surgery

Secondary outcomes

  1. Change in Japanese Orthopaedics Association (JOA) score,

    Time frame: Pre-operation, intraoperative, 6 months and 1 year after surgery

  2. Change in Knee Society Score (KSS)

    Time frame: Pre-operation, intraoperative, 6 months and 1 year after surgery

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Study locations

1 site
  • Fukuoka Tokushukai Hospital.
    Kasuga City, Fukuoka Prefecture 816-0864, Japan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02552082
Lead sponsor
Stryker Japan K.K.
Responsible party
Sponsor
First posted
Sep 16, 2015
Start date
Jun 2015
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Sep 17, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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