UMIN-CTR Clinical Trial

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
Email	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
Email	fujiwara@okuno-y-clinic.com

Sponsor
Institute	Okuno Clinic.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052005