Scorpio Non Restricted Geometry (NRG) Study in Japan

NCT02552082 | Completed

• 1 other identifier: SJCR-OR-1501
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in Range of motion(ROM)

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

Secondary Outcomes (2)

• 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

Study Arms (1)

Scorpio NRG

Device: Scorpio NRG posterior stabilized (PS)

Interventions

Scorpio NRG posterior stabilized (PS) DEVICE

Scorpio NRG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Japan K.K.: lead

Study Sites (1)

Fukuoka Tokushukai Hospital.

Kasuga, Fukuoka, 816-0864, Japan

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: September 16, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)