Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.
- Conditions
- Patients with hip joint disease caused by hip osteoarthritis and others.
- Registration Number
- JPRN-UMIN000012433
- Lead Sponsor
- KYOCERA Medical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
The exclusion criteria having effects on the evaluation of the investigational devices. 1) Patients who had or will have THA or BHA in the opposite hip within 6 months before or after the operation in this clinical trial. 2) Patients who previously had THA or BHA in the opposite hip and it is apparent that prosthesis exhibits loosening. 3) Patients who are difficult to be followed for 6 months after the surgery. 4) Patients who participated clinical trial of another investigational device or drug within 6 months before participating to this clinical trial. 5) Patients who once participated this clinical trial. 6) Patients in unstable clinical conditions or fatal condition. 7) Patients who have clinically serious organ derangement. *Additionally, there are exclusion criteria related to the product characteristics of the investigational devices.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Japanese orthopedic association hip score Serious adverse device effect
- Secondary Outcome Measures
Name Time Method