UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006224 |
|---|---|
| Receipt number | R000007355 |
| Scientific Title | Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/03/28 10:12:06 |
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Basic information
Public title
Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases
Acronym
Clinical study of a new prosthesis for total hip arthroplasty (AMU001)
Scientific Title
Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases
Scientific Title:Acronym
Clinical study of a new prosthesis for total hip arthroplasty (AMU001)
Region
| Japan |
Condition
Condition
Osteoarthritis of the Hip, Osteo necrosis of the Femoral Head, Rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial is conducted for the patients with hip joint diseases. The efficiency and safety of the test device, a new prosthesis for total hip arthroplasty(AMU001), will be evaluated 12 months after surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
JOA Score
Key secondary outcomes
Efficiency:
Radiographic assessment
Safety:
Adverse events
Radiographic assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of a hip prosthesis
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | (1) Hiroshi Ito (2) Takeshi Masuda |
Organization
(1) Asahikawa Medical University Hospital
(2) Eniwa Hospital
Division name
(1) Orthopaedics (2) Orthopaedics
Zip code
Address
(1) Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan (2) 2-1-1, Koganechuou, Eniwa, Hokkaido, Japan
TEL
0166-68-2511
itohiro@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Kato |
Organization
National University Corporation Asahikawa Medical University
Division name
General Affairs Division
Zip code
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2189
Homepage URL
sho-kenkyu@jimu.asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University Hospital Orthopaedics
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Translational Research, Hokkaido University
NAKASHIMA MEDICAL CO, LTD.
Name of secondary funder(s)
NAKASHIMA MEDICAL CO, LTD.
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
①国立大学法人旭川医科大学病院 （北海道）
②医療法人社団我汝会えにわ病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 24 | Day |
Last modified on
| 2014 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007355
