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Trial record 8 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Scorpio Non Restricted Geometry (NRG) Study in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02552082
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoarthritis Rheumatoid Arthritis Device: Scorpio NRG posterior stabilized (PS)

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA
Study Start Date : June 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in Range of motion(ROM) [ Time Frame: Pre-operation, intraoperative, 6 months and 1 year after surgery ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552082


Locations
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Japan
Fukuoka Tokushukai Hospital.
Kasuga City, Fukuoka Prefecture, Japan, 816-0864
Sponsors and Collaborators
Stryker Japan K.K.

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Responsible Party: Stryker Japan K.K.
ClinicalTrials.gov Identifier: NCT02552082     History of Changes
Other Study ID Numbers: SJCR-OR-1501
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases