UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046876 |
|---|---|
| Receipt number | R000053477 |
| Scientific Title | Comparison between fixed bearing and mobile bearing navigated knee arthroplasty - a randomized controlled trial. |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2023/08/16 17:09:02 |
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Basic information
Public title
Comparison between fixed bearing and mobile bearing navigated knee arthroplasty - a randomized controlled trial.
Acronym
Clinical Outcomes of Posterior Stabilized Total Knee Arthroplasty Prosthesis: Comparisons with Two Established Prostheses.
Scientific Title
Comparison between fixed bearing and mobile bearing navigated knee arthroplasty - a randomized controlled trial.
Scientific Title:Acronym
Clinical Outcomes of Posterior Stabilized Total Knee Arthroplasty Prosthesis: Comparisons with Two Established Prostheses.
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of study was compared the clinical outcome between fixed bearing versus mobile bearing postero-stabilized knee arthroplasty with navigation system
Basic objectives2
Others
Basic objectives -Others
The purpose of study was examiend the relationship between clinical outcome and knee kinematics with navigation system.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee Society Score
Knee Osteoarthritis Outcome Score
Key secondary outcomes
range of motion
time up and go test
femorotibial angle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
fix-bearing postero stabilized TKA
twelve month follow up
Interventions/Control_2
mobile-bearing postero stabilized TKA
twelve month follow up
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
| 55 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
knee ostearthritis with resistance of conservative treatment
Key exclusion criteria
Rhematoid arthritis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kanazawa |
Organization
Juntendo Geriatric medical center
Division name
Department of Orhtopaedics Surgery
Zip code
136-0075
Address
3-3-20,Shinsuna,Koutoku, Tokyo
TEL
+815632-3111
h-kanazawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kanazawa |
Organization
Juntendo Geriatric medical center
Division name
Orthopaedic Surgery
Zip code
136-0075
Address
3-3-20,Shinsuna,Koutoku, Tokyo
TEL
0356323111
Homepage URL
h-kanazawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
IRB of Juntendo Geriatric medical center
Address
3-3-20,Shinsuna,Koutoku, Tokyo
Tel
+815632-3111
h-kanazawa@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
G20-0033
Org. issuing International ID_1
Research Ethics Committee, Faculty of medicine,Juntendo University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部附属順天堂東京江東高齢者医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 14 | 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
6
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053477
