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Completed

NCT Number: NCT02552082

Scorpio Non Restricted Geometry (NRG) Study in Japan

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fukuoka Tokushukai Hospital.

Kasuga, Fukuoka, 816-0864, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scorpio NRG posterior stabilized (PS)

Device

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

Sponsors and collaborators

Lead sponsor

Stryker Japan K.K.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2015
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.