UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006224
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sho-kenkyu@jimu.asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University Hospital Orthopaedics
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007355

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.