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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018238
Receipt No. R000020314
Scientific Title Feasibility and effects of transcatheter arterial micro-embolization for persistent pain after knee joint replacement surgery
Date of disclosure of the study information 2015/07/10
Last modified on 2020/02/04

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Basic information
Public title Feasibility and effects of transcatheter arterial micro-embolization for persistent pain after knee joint replacement surgery
Acronym TAME for persistent pain after knee joint replacement
Scientific Title Feasibility and effects of transcatheter arterial micro-embolization for persistent pain after knee joint replacement surgery
Scientific Title:Acronym TAME for persistent pain after knee joint replacement
Region
Japan

Condition
Condition Persistent pain after knee joint replacement surgery
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility and effectiveness of trascatheter arterial micro-embolziation for persistent pain after knee joint replacement surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain VAS
Complication
Key secondary outcomes Oxford knee score
Pain Catastrophizing Scale

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
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
20 years-old <
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria more than 6 months passed after his knee replacement surgery
more than VAS 50mm
Key exclusion criteria clinical evidence of infection
evidence of loosening
radiographic evidence of abnormalities
advanced spinal canal stenosis
advanced arteriosclerosis
malignant tumor
pregnancy
rheumatoid arthritis
depression
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code 133-0052
Address Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL +81-3-3673-1221
Email okuno@okuno-y-clinic.com

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code 133-0052
Address Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL +81-3-3673-1221
Homepage URL
Email okuno@okuno-y-clinic.com

Sponsor
Institute Edogawa Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Toho University,School of Medicine, Department of Orthopedic Surgery
Name of secondary funder(s)

IRB Contact (For public release)
Organization Edogawa Hospital
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
Tel +81-3-3673-1221
Email secretary@edogawa.or.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 江戸川病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 10 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 Completed
Date of protocol fixation
2015 Year 07 Month 14 Day
Date of IRB
2015 Year 07 Month 14 Day
Anticipated trial start date
2015 Year 07 Month 14 Day
Last follow-up date
2018 Year 03 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
2015 Year 07 Month 07 Day
Last modified on
2020 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020314

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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