UMIN-CTR Clinical Trial

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