Patients with hip joint disease caused by hip osteoarthritis and others
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with hip joint disease, who participated in the previous clinical trial using the investigational device, JMM-H01, and consented to this study in written form.
Exclusion criteria
Exclusion criteria: 1) Patients whose JMM-H01 has been retrieved. 2) Patients whom the investigator(s) judged not necessary for further investigation due to worsening of complications. 3) Patients whom the investigator(s) judged not necessary for further investigation due to inappropriateness to participate to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy 1) Survival rate of the investigational device, JMM-H01 2) Radiographic assessment 3) Clinical evaluation -Evaluation chart of hip joint function (Japanese Orthopaedic Association, 1995) -Merle d'Aubigne and Postel score -QOL assessment (SF-36) Safety 1) Adverse events and device deficiency | — |
Countries
Japan
Contacts
KYOCERA Corporation Clinical Development Section Regulatory Affairs & Clinical Development Dept. Medical Division