Tritanium® Study in Japan

NCT02552069 | Unknown

• 1 other identifier: SJCR-OR-1505
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis of the Femoral Head

Outcome Measures

Primary Outcomes (1)

• Change in implantation position(angle) of the cup

  Baseline, intraoperative, 3 months, 6 months and 12 months

Secondary Outcomes (2)

• Change in Japanese Orthopaedic Association (JOA) score

  Baseline, 3 months, 6months and 12 months

• Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D)

  Pre-operation, 3 months, 6months and 12 months

Study Arms (1)

Tritanium® cup

Device: Tritanium® cup

Interventions

Tritanium® cup DEVICE

Tritanium® cup

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 secondary osteoarthritis, avascular necrosis and rheumatoid arthritis

You may qualify if:

• Patient is a candidate for a primary Total Hip Arthroplasty (THA).
• Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis.
• Patient whose age is 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 high risk of a bacterial infection.
• Patient who requires revision surgery of a previously implanted total hip arthroplasty.
• 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 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), which limits ability to evaluate the safety and efficacy of the device.
• Patient who is immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device.
• Patients who is judged ineligible with specific reason by primary doctor.

Sponsors & Collaborators

• Stryker Japan K.K.: lead

Study Sites (1)

RINKU General Medical Center

Izumisano, Osaka, 598-8577, Japan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasuyuki Inatsugu

  Stryker Japan

  STUDY DIRECTOR

Central Study Contacts

Ysuyuki Inatsugu

CONTACT

+81-3-6894-8394; yasuyuki.inatsugu@stryker.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• 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, 2020
• Study Completion: March 1, 2020
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

JP (1)