Tritanium® Study in Japan

The Verification Study on the Early Fixation/ Stability of Tritanium Cup

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis of the Femoral Head
• Intervention / Treatment: Device: Tritanium® cup

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Izumisano, Osaka, Japan, 598-8577
      • Recruiting
      • Rinku General Medical Center
      • Contact: Phone Number: +81-72 - 469 - 3111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in implantation position(angle) of the cup	Baseline, intraoperative, 3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Stryker Japan K.K.
• Investigators: Study Director: Yasuyuki Inatsugu, Stryker Japan

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: SJCR-OR-1505