UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017349
Receipt number R000020106
Scientific Title The effect of synovium for tendon-to-bone insertion healing - microvascularity analysis -
Date of disclosure of the study information 2015/05/01
Last modified on 2016/06/14 21:27:56

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Basic information

Public title

The effect of synovium for tendon-to-bone insertion healing - microvascularity analysis -

Acronym

The effect of synovium for tendon-to-bone insertion healing

Scientific Title

The effect of synovium for tendon-to-bone insertion healing - microvascularity analysis -

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Tadanao Funakoshi

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Orthopaedic surgery

Zip code


Address

Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido

TEL

011-706-5937

Email

tfunakoshi@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Urita

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Orthopaedc surgery

Zip code


Address

Kita14 Nishi5, Kita-ku, Sapporo

TEL

011-706-5937

Homepage URL


Email

uriboh@zg7.so-net.ne.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



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)



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

2015 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2010 Year 08 Month 19 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name