UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023723 |
|---|---|
| Receipt number | R000027327 |
| Scientific Title | Meniscal repair with allograft |
| Date of disclosure of the study information | 2016/08/24 |
| Last modified on | 2019/08/27 18:01:42 |
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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
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
skuwata@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
