Skip to content

Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases

Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases - Clinical study of a new prosthesis for total hip arthroplasty (AMU001)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006224
Enrollment
30
Registered
2011-09-01
Start date
2011-10-01
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

Osteoarthritis of the Hip, Osteo necrosis of the Femoral Head, Rheumatoid arthritis

Interventions

Implantation of a hip prosthesis

Sponsors

Asahikawa Medical University Hospital Orthopaedics
Lead Sponsor
Center for Translational Research, Hokkaido University NAKASHIMA MEDICAL CO, LTD.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Inclusion criteria: 1) Osteoarthritis of the hip: advanced or end stage 2) Osteonecrosis of the Femoral Head: Stage 3A, 3B, or 4 3) Rheumatoid arthritis: Larsen Grade2 or greater than grade 2 (2) JOAscore<=69 (3) Patient's agreement (4) Age>=20

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
JOA Score

Secondary

MeasureTime frame
Efficiency: Radiographic assessment Safety: Adverse events Radiographic assessment

Countries

Japan

Contacts

Public ContactMasaaki Kato

National University Corporation Asahikawa Medical University General Affairs Division

sho-kenkyu@jimu.asahikawa-med.ac.jp0166-68-2189

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026