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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025017
Receipt No. R000028549
Scientific Title Safety and Effectiveness of transcatheter arterial micro-embolization as a treatment for ulnar collateral ligament injuries in baseball players refractory to conservative treatment
Date of disclosure of the study information 2016/11/29
Last modified on 2016/11/28

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Basic information
Public title Safety and Effectiveness of transcatheter arterial micro-embolization as a treatment for ulnar collateral ligament injuries in baseball players refractory to conservative treatment
Acronym TAME for baseball player with resistant UCL Injuries
Scientific Title Safety and Effectiveness of transcatheter arterial micro-embolization as a treatment for ulnar collateral ligament injuries in baseball players refractory to conservative treatment
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuji Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code
Address Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL 03-3673-1221
Email okuno@edogawa.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Okuno
Organization Edogawa Hospital
Division name Musculoskeletal Intervention Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 20 Day
Date of IRB
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

Other
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

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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