UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054575 |
|---|---|
| Receipt number | R000062359 |
| Scientific Title | Dynamic variation of tibiofemoral compression force during total knee arthroplasty: Implications for soft tissue balance and functional outcomes |
| Date of disclosure of the study information | 2024/06/05 |
| Last modified on | 2024/06/05 12:57:36 |
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Basic information
Public title
Dynamic variation of tibiofemoral compression force during total knee arthroplasty: Implications for soft tissue balance and functional outcomes
Acronym
Dynamic variation of tibiofemoral compression force during total knee arthroplasty
Scientific Title
Dynamic variation of tibiofemoral compression force during total knee arthroplasty: Implications for soft tissue balance and functional outcomes
Scientific Title:Acronym
Dynamic variation of tibiofemoral compression force during total knee arthroplasty
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate how tibiofemoral compression force varies across different degrees of knee flexion and assess its correlation with functional outcomes after knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tibiofemoral compression force
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee osteoarthritis
Key exclusion criteria
Rheumatoid arthritis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Orthopedics
Zip code
569-8686
Address
Daigakumachi 2-7, Takatsuki, Osaka
TEL
0726831221
yoshinori.okamoto@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Orthopedics
Zip code
569-8686
Address
Daigakumachi 2-7, Takatsuki, Osaka
TEL
0726831221
Homepage URL
yoshinori.okamoto@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research of Japan Society KAKENHI for the Promotion of Science, Grant Number 17K10989 and 21K09239.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
Daigakumachi 2-7, Takatsuki, Osaka
Tel
0726831221
yoshinori.okamoto@ompu.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
| 2024 | Year | 06 | Month | 05 | 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
86
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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062359
