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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041036
Receipt No. R000046867
Scientific Title Synovitis after Total Knee Arthroplasty - longitudinal study
Date of disclosure of the study information 2020/07/09
Last modified on 2020/07/08

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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
Email 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
Email natsukick40@hotmail.com

Sponsor
Institute Orthopaedics surgery, Kochi University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 01 Day
Date of IRB
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
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046867

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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