UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032420 |
|---|---|
| Receipt number | R000036971 |
| Scientific Title | Clinical results of simultaneous bilateral TKA by two kinds of navigation |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2019/04/29 09:25:34 |
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Basic information
Public title
Clinical results of simultaneous bilateral TKA by two kinds of navigation
Acronym
Clinical results of simultaneous bilateral TKA by two kinds of navigation
Scientific Title
Clinical results of simultaneous bilateral TKA by two kinds of navigation
Scientific Title:Acronym
Clinical results of simultaneous bilateral TKA by two kinds of navigation
Region
| Japan |
Condition
Condition
osteoarthritis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of postoperative results of TKA using two kinds of navigation in simultaneous bilateral cases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
raduological alignment of femoral and tibial component
(xp, CT)
Key secondary outcomes
operation time, bleeding volume
complication rate such assubcutaneous hematoma, delayed healing of the wound, SSI, pin implant part fractures
postoperative clinical results
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
one side is operated by GPS system
Interventions/Control_2
the othe side is operated by Knee Align 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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
OA knee planning simultanrous bilateral TKA
Key exclusion criteria
severe obesity
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ojima |
Organization
Fukui General Hospital
Division name
Dept. of Orthopaedic Surgery
Zip code
108561
Address
58-16-1, Egami, Fukui
TEL
0776-59-1300
ojima@ka2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ojima |
Organization
Fukui General Hospital
Division name
Dept. of Orthopaedic Surgery
Zip code
9108561
Address
58-16-1, Egami, Fukui
TEL
0776-59-1300
Homepage URL
ojima@ka2.so-net.ne.jp
Sponsor or person
Institute
Fukui General Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukui General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui General Hospital
Address
58-16-1, Egami, Fukui
Tel
0776-59-1300
fgh-hisyo@mopera.net
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
| 2018 | Year | 05 | 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
100
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 28 | Day |
Last modified on
| 2019 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036971
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
