UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015347 |
|---|---|
| Receipt number | R000017853 |
| Scientific Title | FUJI Study (Functional evaluation Using JOURNEY Implant) |
| Date of disclosure of the study information | 2016/10/16 |
| Last modified on | 2016/06/28 10:07:59 |
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Basic information
Public title
FUJI Study (Functional evaluation Using
JOURNEY Implant)
Acronym
FUJI Study
Scientific Title
FUJI Study (Functional evaluation Using
JOURNEY Implant)
Scientific Title:Acronym
FUJI Study
Region
| Japan |
Condition
Condition
Total Knee Arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate comprehensively satisfaction, safety,
subjective/objective knee function, and
component position between JOURNEY II
BCS and conventional total knee systems in
multicenter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2011 New Knee Society Score Satisfaction
Key secondary outcomes
2011 New Knee Society Score Functional
Charnley Functional Classification, Alignment,
Stability, ROM, Expactation, Activity,
UCLA Activity Score,
Range of Motion
Pain Evaluation
etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
JOURNEY II BCS
Interventions/Control_2
Conventional total knee system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subject requires primary total knee
arthroplasty
2) Subject has knee osteoarthritis
Key exclusion criteria
1) Subject has dementia
2) Subject has rheumatoid arthritis of knee
3) Subject after high tibial osteotomy
4) Subject after fracture of lower limb
(Subject after knee arthroscopy and subject
has bilateral knee osteoarthritis)
Target sample size
672
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Akagi |
Organization
Kinki University
Division name
Faculty of Medicine, Department of Orthopaedics
Zip code
Address
377-2, Ono-higashi, Osaka Sayama-city, Osaka-fu
TEL
072-366-0221
makagi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeshi Mori |
Organization
Kinki University
Division name
Faculty of Medicine, Department of Orthopaedics
Zip code
Address
377-2, Ono-higashi, Osaka Sayama-city, Osaka-fu
TEL
072-366-0221
Homepage URL
smori@med.kindai.ac.jp
Sponsor or person
Institute
Department of Orthopaedics, Faculty of Medicine, Kinki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 06 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017853
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
