Tritanium® Study in Japan

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02552069
• Other study ID #: SJCR-OR-1505
• Status: Recruiting
• Start date: June 2015
• Est. completion date: March 2020

Study information

• Verified date: September 2018
• Source: Stryker Japan K.K.
• Contact: Ysuyuki Inatsugu
• Phone: +81-3-6894-8394
• Email: yasuyuki.inatsugu[@]stryker.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Avascular Necrosis of the Femoral Head
• Femur Head Necrosis
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Tritanium® cup

Locations

Country	Name	City	State
Japan	RINKU General Medical Center	Izumisano	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in implantation position(angle) of the cup		Baseline, intraoperative, 3 months, 6 months and 12 months
Secondary	Change in Japanese Orthopaedic Association (JOA) score		Baseline, 3 months, 6months and 12 months
Secondary	Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D)		Pre-operation, 3 months, 6months and 12 months