Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.

Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty. - Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012433

Enrollment

Registered

2013-12-01

Start date

2013-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hip joint disease caused by hip osteoarthritis and others.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with an indication for THA who are selected by orthopedic specialist of the JOA and consented to the operation. 2) Inpatients or outpatients with a written first-person consent. 3) Patients aged 20 and over. (Not gender specific)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Japanese orthopedic association hip score Serious adverse device effect	—

Countries

Japan

Contacts

Public ContactKiyoyasu fujii

KYOCERA Medical Corporation Regulatory Affairs Development Dept. Research and Development Corporate Division

kiyoyasu.fujii@kyocera-md.jp06-6350-1493

Outcome results