UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026343 |
|---|---|
| Receipt number | R000030262 |
| Scientific Title | Evaluation replacement accuracy in total knee arthroplasty using JIGEN |
| Date of disclosure of the study information | 2017/02/28 |
| Last modified on | 2021/09/04 07:59:18 |
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Basic information
Public title
Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Acronym
Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Scientific Title
Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Scientific Title:Acronym
Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Region
| Japan |
Condition
Condition
osteoarthritis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate implant replacement accuracy of total knee arthroplasty using JIGEN wchich is computer assisted preoperative planning system/
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee society radiographical implant replacement angke(preoperative, PO1M, PO3Ms, PO6Ms, PO12Ms, PO24Ms)
Key secondary outcomes
Clinical outcome-knee society score, KOOS
(preoperative, PO1M, PO3Ms, PO6Ms, PO12Ms, PO24Ms
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
Computer assisted operation supported system: JIGEN
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
| 40 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis of the knee joint
Key exclusion criteria
1)TKA postoperative infection
2)Second sexual gonarthrosis example by primary disease except primary gonarthrosis
3)The patient having affiliation symptom
4)The patient having rheumatic arthritis
5)The patient after high tibial osteotomy
6)The patient having episode of leg fracture
7)Out of gravid or the woman who has pregnant possibilities.The man and woman who do not agree to a woman nursing and contraception studying
8)In addition, the proband whom Rev. study person in charge or doctor in charge judged to be inadequate to carry out this study safely
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Tsukimura |
Organization
Kitasato insutitite hospital, Kitasato university
Division name
Artificial joint and cartilage implantimplantation center
Zip code
Address
5-9-1 shirokane, minato-ku, Tokyo, Japan
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 insutitite hospital, Kitasato university
Division name
Artificial joint and cartilage implantimplantation center
Zip code
Address
5-9-1 shirokane, minato-ku, Tokyo, Japan
TEL
03-3444-6161
Homepage URL
tsukky@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato insutitite hospital, Kitasato university
Institute
Department
Personal name
Funding Source
Organization
Kitasato insutitite 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
| 2017 | Year | 02 | Month | 28 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030262
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
