Tritanium® Study in Japan

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis of the Femoral Head
• Interventions: Device: Tritanium® cup

• Registration Number: NCT02552069
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tritanium® cup	Tritanium® cup	-

Primary Outcome Measures

Name	Time	Method
Change in implantation position(angle) of the cup	Baseline, intraoperative, 3 months, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

RINKU General Medical Center; 🇯🇵 Izumisano, Osaka, Japan