UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024038 |
|---|---|
| Receipt number | R000027682 |
| Scientific Title | Motion analysis of Balanced knee TriMax PS-type and CR-type TKA |
| Date of disclosure of the study information | 2016/09/13 |
| Last modified on | 2019/03/19 22:31:15 |
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Basic information
Public title
Motion analysis of Balanced knee TriMax PS-type and CR-type TKA
Acronym
TriMax motionanalysis
Scientific Title
Motion analysis of Balanced knee TriMax PS-type and CR-type TKA
Scientific Title:Acronym
TriMax motionanalysis
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate motion analysis after the TKA whether Balanced knee Trimax gaines normal knee joint motion.
Basic objectives2
Others
Basic objectives -Others
Motionnanalysiis date is comparewwd with clinical outcome scale.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3 dimensional knee motion analysis using 2D/3/D registration method at walking, step and kneing 6 months over postoperatively after the TKA.
Key secondary outcomes
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
Total knee arthroplasty
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
| 35 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Osteoarthritic patients were underwent Trimax total knee arthroplasty 6 months over postoperatively, and gained normal AD./
Key exclusion criteria
Osteoarthritic patients were not underwent Trimax total knee arthroplasty, or within 6 months
RA
osteoarthritis patient with fracture, inflammational disease, gene disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Tsukimura |
Organization
Kitasato insutitute hospital, Kitasato university
Division name
Artificial joint and chondral implantation center
Zip code
Address
1-55-13, Shirokane, Minatoku, Tokyo
TEL
03-3444-6161
tsukky@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Tsukimura |
Organization
Kitasato insutitute hospital, Kitasato university
Division name
Artificial joint and chondral implantation center
Zip code
Address
1-55-13, Shirokane, Minatoku, Tokyo
TEL
03-3444-6161
Homepage URL
tsukky@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato insutitute hospital, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Orthpaedic, Kitasato insutitute hospital, Kitasato university
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 | 09 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027682
