UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018238 |
|---|---|
| Receipt number | 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 15:43:07 |
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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
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
okuno@okuno-y-clinic.com
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020314
