Scorpio Non Restricted Geometry (NRG) Study in Japan

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552082
• Other study ID #: SJCR-OR-1501
• Status: Completed
• Start date: June 2015
• Est. completion date: March 2018

Study information

• Verified date: September 2018
• Source: Stryker Japan K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Scorpio NRG posterior stabilized (PS)

Locations

Country	Name	City	State
Japan	Fukuoka Tokushukai Hospital.	Kasuga City	Fukuoka Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Range of motion(ROM)		Pre-operation, intraoperative, 6 months and 1 year after surgery
Secondary	Change in Japanese Orthopaedics Association (JOA) score,		Pre-operation, intraoperative, 6 months and 1 year after surgery
Secondary	Change in Knee Society Score (KSS)		Pre-operation, intraoperative, 6 months and 1 year after surgery