UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044354 |
|---|---|
| Receipt number | R000050656 |
| Scientific Title | The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/05/28 11:54:56 |
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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
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
sugimura.n@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050656
