Scorpio Non Restricted Geometry (NRG) Study in Japan

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis
• Intervention / Treatment: Device: Scorpio NRG posterior stabilized (PS)

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Japan
  • Fukuoka Prefecture
    • Kasuga City, Fukuoka Prefecture, Japan, 816-0864
      • Fukuoka Tokushukai Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Scorpio NRG	Device: Scorpio NRG posterior stabilized (PS)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Stryker Japan K.K.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SJCR-OR-1501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No