UMIN-CTR Clinical Trial

Basic information
Public title	The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty
Acronym	The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty
Scientific Title	The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty
Scientific Title:Acronym	The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty
Region	Japan

Condition
Condition	Chronic post-surgical pain after total knee arthroplasty
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although total knee arthroplasty (TKA) is an effective treatment for osteoarthritis (OA), postoperative persistent pain may occur and patient satisfaction may be compromised. We have evaluated post-TKA synovitis (total PD score) using the power Doppler method (PD) of the ultrasonography (US), and have found that post-TKA persistent pain is related to the total PD score. post-TKA synovitis is considered to be a new cause of post-TKA persistent pain, and the development of a treatment method is urgently needed. The purpose of this study is to provide a pilot single-arm prospective study of transcatheter arterial micro-embolization (TAME) in patients with persistent pain and to gain a foothold for the treatment of post-TKA synovitis with TAME.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain VAS during walking after 6 months of TAME
Key secondary outcomes	Pain VAS at 3, 6, and 12 months after TAME, WOMAC score, assessment of pain and function at 3, 6, and 12 months using the WOMAC score, and assessment of the number and type of adverse events from TAME to the 12-month assessment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	transcatheter arterial micro-embolization (TAME)
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 with post-TKA prolonged pain (pain VAS 30 or more) who have received conservative therapy for 3 months and have prolonged pain due to post-TKA synovitis.
Key exclusion criteria	Patients who meet the following criteria: no other conditions that cause pain, no anticoagulant medication, synovitis confirmed by ultrasound, and no problems with surgery on preoperative examination.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Natsuki Middle name Last name Sugimura
Organization	Department of Orthopaedics, Kochi University
Division name	Orthopaedics surgery
Zip code	783-8505
Address	185-1 Kohasu, Okochom, Nankoku, Kochi, Japan
TEL	0888802386
Email	sugimura.n@kochi-u.ac.jp

Public contact
Name of contact person	1st name Natsuki Middle name SUGIMURA Last name Sugimura
Organization	Kochi university
Division name	Department orthopaedics surgery
Zip code	783-8505
Address	185-1 Oko-cho Kohasu
TEL	0888802386
Homepage URL
Email	sugimura.n@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	Kochi university
Address	Nankoku
Tel	0888802386
Email	sugimura.n@kochi-u.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	2021 Year 06 Month 01 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	2021 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2025 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	2021 Year 05 Month 28 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=R000050656