UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041036 |
|---|---|
| Receipt number | R000046867 |
| Scientific Title | Synovitis after Total Knee Arthroplasty - longitudinal study |
| Date of disclosure of the study information | 2020/07/09 |
| Last modified on | 2021/05/28 12:00:14 |
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Basic information
Public title
Synovitis after Total Knee Arthroplasty - longitudinal study
Acronym
Synovitis after Total Knee Arthroplasty - longitudinal study
Scientific Title
Synovitis after Total Knee Arthroplasty - longitudinal study
Scientific Title:Acronym
Synovitis after Total Knee Arthroplasty - longitudinal study
Region
| Japan |
Condition
Condition
osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although chronic postsurgical pain(CPSP) after total knee arthroplasty(TKA) is unknown, synovitis after TKA is suspected as one of the causes of it. In this study, we will investigate the relationship between pain and synovitis after TKA.
Basic objectives2
Others
Basic objectives -Others
We will investigate the cause of synovitis after TKA.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain scale(pain VAS) in postoperative six month
Key secondary outcomes
postoperative alignment of implants, knee instability, age at the surgery, preoperative PD total score, and CRP of synovial fluid.
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who will be performed CS type TKA.
Key exclusion criteria
patients having history of pyogenic arthritis of the knee, Lumber spine stenosis, postoperative neuropathic pain in wound of TKA, and post operative infection.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Sugimura |
Organization
Kochi University
Division name
Orthopeadics surgery
Zip code
7838505
Address
185-1 Oko-cho Kohasu, Nankoku, Kochi, Japan
TEL
088-880-2386
natsukick40@hotmail.com
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | SUGIMURA |
| Last name | Sugimura |
Organization
Kochi university
Division name
Orthopeadics Surgery
Zip code
783-8505
Address
185-1 Oko-cho Kohasu, Nankoku, Kochi, Japan
TEL
088-880-2386
Homepage URL
natsukick40@hotmail.com
Sponsor or person
Institute
Orthopaedics surgery, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi University
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
Kochi university
Address
185-1 Oko-cho Kohasu, Nankoku, Kochi, Japan
Tel
088-880-2386
natsukick40@hotmail.com
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
| 2020 | Year | 07 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative PD total score on ultrasonography, preoperative CRP level and white blood cell count in synovial fluid, postoperative implant position, alignment, instability, age at the surgery, postoperative six months pain VAS, and PD total score will be evaluated. Statistically, we set pain VAS as objective variables and the others as explanatory variables and perform multiple regression analysis.
Management information
Registered date
| 2020 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046867
