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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031714
Receipt No. R000036223
Scientific Title Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Date of disclosure of the study information 2018/03/15
Last modified on 2018/03/14

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Basic information
Public title Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Acronym Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Scientific Title Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Scientific Title:Acronym Efficacy of bone marrow stimulation in arthroscopic rotator cuff repair
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study was to compare the clinical outcomes and structual integrity of arthroscopic rotator cuff repairs with and without bone marrow stimulation. This was a prospective randomized study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tendon heeling was assessed 6-, 12-,24-months after the operation on magnetic resonance images
Key secondary outcomes Functional evaluation of the shoulder was performed with the UCLA score and Constant-Murley shoulder outcome score and self-reporting scale(Simple Shoulder test) .The scores obtained preoperative and 6-, 12-,24-months after the operation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 repair with bone marrow stimulation
Interventions/Control_2 arthroscopic rotator cuff repair without bone marrow stimulation
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with full-thickness rotator cuff tears undergoing primary arthroscopic rotator cuff repair
Reparable rotator cuff tears under arthroscopic surgery.
Key exclusion criteria History of shoulder fracture or dislocation and prior surgery to the affected shoulder.
Inflammatory or neurologic disease.
Irreparable rotator cuff tears under arthroscopic surgery.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terufumi Shibata
Organization Fukuoka University Faculty of Medicine
Division name Dept.of Orthop.Surg
Zip code
Address 7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL 092-801-1011
Email teru-sky-ideal@lion.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Terufumi Shibata
Organization Fukuoka University Faculty of Medicine
Division name Dept.of Orthop.Surg
Zip code
Address 7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL 092-801-1011
Homepage URL
Email teru-sky-ideal@lion.ocn.ne.jp

Sponsor
Institute Fukuoka University Faculty of Medicine
Dept.of Orthop.Surg
Institute
Department

Funding Source
Organization None
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
2018 Year 03 Month 15 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
2017 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 10 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
2018 Year 03 Month 14 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036223

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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