UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046834 |
|---|---|
| Receipt number | R000052005 |
| Scientific Title | Effects of Intra-Arterial Infusion of temporary embolic material for hand osteoarthritis Refractory to Conservative Treatment: A Retrospective Study |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2022/03/28 01:15:27 |
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Basic information
Public title
Effects of Intra-Arterial Infusion of temporary embolic material for hand osteoarthritis Refractory to Conservative Treatment: A Retrospective Study
Acronym
Retrospective study of simplified TAE For hand OA
Scientific Title
Effects of Intra-Arterial Infusion of temporary embolic material for hand osteoarthritis Refractory to Conservative Treatment: A Retrospective Study
Scientific Title:Acronym
Retrospective study of simplified TAE For hand OA
Region
| Japan |
Condition
Condition
osteoarthritis in DIP/PIP joints
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of simplified TAE for patients with refractory hand OA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of pain score at 1 year follow up
Key secondary outcomes
Complications
Change of Quick DASH score
pain PGIC
swelling PGIC
redness PGIC
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
we perform a retrospective study assessing the clinical course of patients who underwent simplified TAE during 2019 to 2020
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Okuno |
Organization
Okuno Clinic.
Division name
Musculoskeletal Intervention Center
Zip code
1060032
Address
4th Fl Ginrrei Bldg. 7-8-4, Roppongi, Minato-ku, Tokyo
TEL
+81-3-6801-6539
okuno@okuno-y-clinic.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Fujiwara |
Organization
Okuno Clinic.
Division name
Clinical Research Center
Zip code
1060032
Address
4th Fl Ginrrei Bldg. 7-8-4, Roppongi, Minato-ku, Tokyo
TEL
+81-3-6801-6539
Homepage URL
fujiwara@okuno-y-clinic.com
Sponsor or person
Institute
Okuno Clinic.
Institute
Department
Personal name
Funding Source
Organization
TAME Study group
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
Ethical committee of Okuno Clinic.
Address
4th Fl Ginrrei Bldg. 7-8-4, Roppongi, Minato-ku, Tokyo
Tel
+81-3-6801-6539
fujiwara@okuno-y-clinic.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
| 2022 | Year | 02 | 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
101
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively evaluated the patients who underwent TAE for hand OA between January 2019 and December 2020.
Management information
Registered date
| 2022 | Year | 02 | Month | 04 | Day |
Last modified on
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052005
