Scorpio Non Restricted Geometry (NRG) Study in Japan

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis
• Interventions: Device: Scorpio NRG posterior stabilized (PS)

• Registration Number: NCT02552082
• Lead Sponsor: Stryker Japan K.K.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Scorpio NRG	Scorpio NRG posterior stabilized (PS)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fukuoka Tokushukai Hospital.; 🇯🇵 Kasuga City, Fukuoka Prefecture, Japan