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Trial record 15 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Tritanium® Study in Japan

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ClinicalTrials.gov Identifier: NCT02552069
Recruitment Status : Recruiting
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 early fixation and stability of the Tritanium cup. It is expected that the Tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.

Condition or disease Intervention/treatment
Osteoarthritis Rheumatoid Arthritis Avascular Necrosis of the Femoral Head Device: Tritanium® cup

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Verification Study on the Early Fixation/ Stability of Tritanium Cup
Study Start Date : June 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tritanium® cup Device: Tritanium® cup



Primary Outcome Measures :
  1. Change in implantation position(angle) of the cup [ Time Frame: Baseline, intraoperative, 3 months, 6 months and 12 months ]

Secondary Outcome Measures :
  1. Change in Japanese Orthopaedic Association (JOA) score [ Time Frame: Baseline, 3 months, 6months and 12 months ]
  2. Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D) [ Time Frame: Pre-operation, 3 months, 6months and 12 months ]


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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 secondary osteoarthritis, avascular necrosis and rheumatoid arthritis
Criteria

Inclusion Criteria:

  1. Patient is a candidate for a primary Total Hip Arthroplasty (THA).
  2. Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis.
  3. Patient whose age is 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 high risk of a bacterial infection.
  2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
  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 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), which limits ability to evaluate the safety and efficacy of the device.
  7. Patient who is immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device.
  8. Patients 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): NCT02552069


Contacts
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Contact: Ysuyuki Inatsugu +81-3-6894-8394 yasuyuki.inatsugu@stryker.com

Locations
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Japan
RINKU General Medical Center Recruiting
Izumisano, Osaka, Japan, 598-8577
Contact    +81-72 - 469 - 3111      
Sponsors and Collaborators
Stryker Japan K.K.
Investigators
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Study Director: Yasuyuki Inatsugu Stryker Japan

Additional Information:

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Responsible Party: Stryker Japan K.K.
ClinicalTrials.gov Identifier: NCT02552069     History of Changes
Other Study ID Numbers: SJCR-OR-1505
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Femur Head Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Osteonecrosis
Bone Diseases