Patients with hip joint disease caused by hip osteoarthritis and others.
Conditions
Interventions
investigational material(s)
Generic name etc : JMM-H01
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : total hip arthr
Sponsors
KYOCERA Medical Corporation
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 from 40 to 75 (Not gender specific) 4) Patients with JOA score no better than 65 before THA
Exclusion criteria
Exclusion criteria: Main criteria 1) As for operative hip (1)Patients who previously had THA, osteotomy, or muscle release operation 2) As for opposite hip (1)Patients who had THA, osteotomy, or muscle release operation within a year prior to this clinical trial (2)Patients who previously had THA and the artificial joint is obviously loosened. (3)Patients who are planed to have THA, osteotomy, or muscle release operation within a year 3) Patients of multijoint disease who are diagnosed as category C by Charnley classification. 4) Patients with 80kg or more in weight, or with Body Mass Index (BMI) of 27 or more. 5) Patients who indicate or show local irritations, abscesses, pyrexia, acute bone absorption and the other symptom of infection at or around the place that the implant is used, or the ones who shows an accelerated erythrocyte sedimentation rate. 6) Patients who have pseudo- or true-metal allergy, have anaphylaxis, or have documented history of allergy or hypersensitivity to 2-methacryloyloxyethyl phosphorylcholine (MPC) and analogues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy 1) Revision or extraction of the investigational device after THA 2) JOA score 3) X-ray photograph Safety 1) Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Improved level of JOA score 2) X-ray photograph 3) QOL assessments | — |
Outcome results
None listed