UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Meniscal repair with allograft
Title of the study (Brief title)	Meniscal repair with allograft
Region	Japan

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

Objectives
Narrative objectives1	To clarify the effectiveness and safety of meniscal allogaraft
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical symptom
Key secondary outcomes	Physical findings, Knee score, Images, Blood examination

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	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 injury. * The cartilage of the knee joint degenerated after lateral meniscectmy. * The age when agreeing, is more than 20 years old and less than 65 years old. * Consent is got by a document from the person himself about study participation.
Key exclusion criteria	rheumatoid arthritis infection
Target sample size	2

Research contact person
Name of lead principal investigator	Yuji Uchio
Organization	Shimane University
Division name	Department of Orthopaedic Sugery
Address	89-1 Enya-cho Izumo city
TEL	0853-20-2240
Email	uchio@med.shimane-u.ac.jp

Public contact
Name of contact person	Yuko Tomii
Organization	Clinical Research Center
Division name	Devision of Clinical reseach
Address	89-1 Enya-cho Izumo city
TEL	0853-20-2259
Homepage URL	http://www.med.shimane-u.ac.jp/
Email	kenkyu@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization	Shimane University Department of Orthopaedic Surgery
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 10 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 13 Day
Anticipated trial start date	2015 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 03 Day
Last modified on	2016 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027950