Tritanium® Study in Japan

• Sponsor: Stryker Japan K.K. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02552069
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 57
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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	Phase
Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis of the Femoral Head	Device: Tritanium® cup

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Verification Study on the Early Fixation/ Stability of Tritanium Cup
• Study Start Date: Jun 1, 2015
• Anticipated Primary Completion Date: Mar 1, 2020
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Tritanium® cup	Device: Tritanium® cup

Outcome Measures

Primary Outcome Measures

1. Change in implantation position(angle) of the cup [Baseline, intraoperative, 3 months, 6 months and 12 months]

Secondary Outcome Measures

1. Change in Japanese Orthopaedic Association (JOA) score [Baseline, 3 months, 6months and 12 months]

2. Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D) [Pre-operation, 3 months, 6months and 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RINKU General Medical Center	Izumisano	Osaka	Japan	598-8577

Sponsors and Collaborators

• Stryker Japan K.K.

Investigators

• Study Director: Yasuyuki Inatsugu, Stryker Japan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Japan K.K.
• ClinicalTrials.gov Identifier: NCT02552069
• Other Study ID Numbers: SJCR-OR-1505
• First Posted: Sep 16, 2015
• Last Update Posted: Sep 17, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Necrosis

Study Results

No Results Posted as of Sep 17, 2018