UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018688 |
|---|---|
| Receipt number | R000021631 |
| Scientific Title | Evaluation of component position after total knee arthroplasty using navigation system: a prospective study |
| Date of disclosure of the study information | 2015/08/17 |
| Last modified on | 2017/08/21 08:24:50 |
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Basic information
Public title
Evaluation of component position after total knee arthroplasty using navigation system: a prospective study
Acronym
Component position after navigated total knee arthroplasty
Scientific Title
Evaluation of component position after total knee arthroplasty using navigation system: a prospective study
Scientific Title:Acronym
Component position after navigated total knee arthroplasty
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare accuracy of component position and clinical score in navigated total knee arthroplasty between balanced and measured-resection techniques
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiograph, CT and clinical evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Balanced methods
Interventions/Control_2
Mesured resection method
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with knee osteoarthritis and treatment of total knee arthroplasty
Key exclusion criteria
Deformity due to previous operation or injury
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Akamatsu |
Organization
Yokohama City University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2655
akamatsu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Akamatsu |
Organization
Yokohama City University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2655
Homepage URL
akamatsu@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery,
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Yokohama City University Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 16 | 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
| 2015 | Year | 08 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021631
