UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and Effectiveness of transcatheter arterial micro-embolization as a treatment for ulnar collateral ligament injuries in baseball players refractory to conservative treatment
Title of the study (Brief title)	TAME for baseball player with resistant UCL Injuries
Region	Japan Asia(except Japan) Europe

Condition
Condition	Ulnar collateral ligament injuries in baseball player refractory to conservative treatment
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the safety and effectiveness of transcatheter arterial micro-embolization for baseball player with ulnar collateral ligament injuries refractory to conservative treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Prevalence of adverse events
Key secondary outcomes	Rates of return to play Rates of return to the same level of play or higher The change of Pain NRS scores The Change of Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow Score The Change of Disabilities of the Arm, Shoulder and Hand Score The change of Pitching Velocity The change of Number of Full strength throwing per day The change of MRI findings The change of US findings

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	16 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	1.Baseball player 2.Diagnosed as UCL injuries by physical examination and confirmed by MRI 3.The patients who can not perform pitching due to his/her pain. 4.The patients who failed to improved his/her symptoms by nonoperative management for more than 3 months
Key exclusion criteria	The patients whose chief complain is not pain The patients who are not available for 1 year follow up the patients who have history of Allergy to contrast enhanced
Target sample size	33

Research contact person
Name of lead principal investigator	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention Center
Address	Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Email	okuno@edogawa.or.jp

Public contact
Name of contact person	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention Center
Address	Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Homepage URL
Email	okuno@edogawa.or.jp

Sponsor
Institute	Edogawa Hospital
Institute
Department

Funding Source
Organization	Orthopedic department of Edogawa Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 20 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 28 Day
Last modified on	2016 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028549