Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases
- Conditions
- Osteoarthritis of the Hip, Osteo necrosis of the Femoral Head, Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000006224
- Lead Sponsor
- Asahikawa Medical University Hospital Orthopaedics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
(1) Patient had previously received hip prosthesis in the same hip joint. (2) Patient received artificial joint prosthesis in lower extremity within 180 days. (3) In the other side of the hip; 1) loosening of total hip arthroplasty or hemiarthroplasty 2) osteotomy or soft tissue release around hip joint is scheduled within one year (4) Charnley category C (5) Body weight>=80kg, BMI>=30 (6) Severe osteoporosis (7) Abscess or infection around hip joint (8) Metal allergy (9) It is difficult to follow the hip precautions due to neurological disorder, mental illness, alcohol dependence, or drug abuse. (10) joined other clinical trial within 90 days (11) in pregnancy or scheduled to become pregnant during this clinical trial. (12) it is not possible to stop to use anticoagulant or antiplatelet drug from one week before surgery. (13) Patient who is determined to be excluded from the clinical trial due to any reasons by the study doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method JOA Score
- Secondary Outcome Measures
Name Time Method Efficiency: Radiographic assessment Safety: Adverse events Radiographic assessment