UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of synovium for tendon-to-bone insertion healing - microvascularity analysis -
Title of the study (Brief title)	The effect of synovium for tendon-to-bone insertion healing
Region	Japan

Condition
Condition	rotator cuff tear
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of synovium for tendon-to-bone insertion healing in the patient with rotator cuff tear using contrast enhanced ultrasound.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	microvascular pattern in tendon-to-bone insertion and synovium after rotator cuff repair.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Arthroscopic rotator cuff tear
Interventions/Control_2	Opne rotator cuff tear
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	35 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. small to midium size rotator cuff tear 2. Over 35 years old 3. Informed concent
Key exclusion criteria	1. Drug Allergy 2. Egg allergy 3. Shunt in heart or lung 4. Severe heart disease 5. Severe lung disease
Target sample size	34

Research contact person
Name of lead principal investigator	Tadanao Funakoshi
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Orthopaedic surgery
Address	Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5937
Email	tfunakoshi@gmail.com

Public contact
Name of contact person	Atsushi Urita
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Orthopaedc surgery
Address	Kita14 Nishi5, Kita-ku, Sapporo
TEL	011-706-5937
Homepage URL
Email	uriboh@zg7.so-net.ne.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2015 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 19 Day
Anticipated trial start date	2010 Year 09 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 30 Day
Last modified on	2016 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020106