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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023723
Receipt No. R000027327
Scientific Title Meniscal repair with allograft
Date of disclosure of the study information 2016/08/24
Last modified on 2019/08/27

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Basic information
Public title Meniscal repair with allograft
Acronym Menisacal allograft
Scientific Title Meniscal repair with allograft
Scientific Title:Acronym Menisacal allograft
Region
Japan

Condition
Condition meniscal injury
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of meniscal allograft for meniscal injuries
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical symptoms at 48 weeks postoperatively
Key secondary outcomes

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
Other
Interventions/Control_1 Investigation for 48 weeks after meniscal allograft
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria * It's diagnosed as meniscal injueries of a knee joint.
* The cartilage is regeneration after partial lateral meniscectomy.
* Consent is got by a document from the person himself about study participation.
Key exclusion criteria Rheumatoid arthritis or infection of the knee joint
Target sample size 2

Research contact person
Name of lead principal investigator
1st name Uchio
Middle name
Last name Yuji
Organization Shimane University
Division name Department of Orthopaedic Surgery
Zip code 693-8501
Address 89-1 Enya-cho Izumo city
TEL 0853-20-2242
Email uchio@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Suguru
Middle name
Last name Kuwata
Organization Shimane University School of Medecine
Division name Department of Orthopaedic Surgery
Zip code 693-8501
Address 89-1 Enya-cho Izumo city
TEL 0853-20-2242
Homepage URL
Email skuwata@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
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 Shimane University Clincal Research Center
Address 89-1 Enya-cho Izumo city
Tel 0853-20-2259
Email kenkyu@med.shimane-u.ac.jp

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 08 Month 24 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
Date of protocol fixation
2015 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 30 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 08 Month 23 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027327

Research Plan
Registered date File name
2016/10/05 実施計画書(同種半月板移植)rev.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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