UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031199 |
|---|---|
| Receipt number | R000035568 |
| Scientific Title | Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2024/02/14 09:51:31 |
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Basic information
Public title
Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty
Acronym
Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty
Scientific Title
Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty
Scientific Title:Acronym
Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the postoperative knee motion for patients who underwent TKA with a mobile medial pivot type implant and to evaluate whether the knee motions are same as design concept that is like a normal knee.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee squatting motion at 6 months after surgery.
Evaluation parameter
:The amount of anteroposterior movement of the femur relative to the tibia
:Rotation angle of the femur relative to the tibia
:Motion pattern of the femur relative to the tibia
:Motion pattern of the insert
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
radiation exposure
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
varus osteoarthritis of the knee
Key exclusion criteria
valgus osteoarthritis of the knee
RA
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Tanifuji |
Organization
Niigata University Medical and Dental General Hospital
Division name
division of orthopedic surgery
Zip code
951-8510
Address
1-757, Asahimachidori, Chuoku, Niigata City, Niigata
TEL
025-227-2272
tanifuji06242000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Tanifuji |
Organization
Niigata University Medical and Dental General Hospital
Division name
division of orthopedic surgery
Zip code
951-8510
Address
1-757, Asahimachidori, Chuoku, Niigata City, Niigata
TEL
025-227-2272
Homepage URL
tanifuji06242000@yahoo.co.jp
Sponsor or person
Institute
Niigata University Medical and Dental General Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata University Medical and Dental General Hospital
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
Niigata University Medical and Dental General Hospital
Address
1-757, Asahimachidori, Chuoku, Niigata City, Niigata
Tel
025-225-2625
ethics@adm.niigata-u.ac.jp
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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2018 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035568
