UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022600 |
|---|---|
| Receipt number | R000026050 |
| Scientific Title | The study of tissue regeneration and promotion of heeling for meniscal tear and regenerative meniscus. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2021/06/08 16:10:59 |
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Basic information
Public title
The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Acronym
The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Scientific Title
The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Scientific Title:Acronym
The study of tissue regeneration and
promotion of heeling for meniscal
tear and regenerative meniscus.
Region
| Japan |
Condition
Condition
meniscal tear
degenerative meniscus
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to improve symptoms
by promoting blood flow by physical
stimulation to the meniscus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence or absence of improvement in symptoms with a focus on IKDC scor
Key secondary outcomes
The presence or absence of improvement in MRI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control
Interventions/Control_2
Interventions
Extracorporeal shock wave irradiation group
Start the irradiation at 0.01mj / mm2 with no anesthesia using DUOLITH SD1(STORTS Medical CO,. Ltd.) Gradually energy while irradiating the 500 shots continue up until 0.25mj / mm2, it is irradiated with 2000 shots. This is enforced three times every other week.
Interventions/Control_3
Interventions
Ultrasound irradiation group
3 weeks irradiation every day for 20 minutes of ultrasound using SAFHS 4000J(TEIJIN Pharma CO,. Ltd.)
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
1 Over 20 year old patient diagnosed with meniscal tear in MRI.
2 Osteoarthritis of knee patient diagnosed Kellgren-Laurence classification 1-2 with meniscal degeneration in MRI.
Key exclusion criteria
1 cases with underlying disease such as rheumatoid arthritis, traumatic knee osteoarthritis, psedogout.
2 cases treated with anti-inflammatory analgesic and opioid, Neurotropin within 2 weeks prior to start of this study.
3 cases treated with steroid oral and intra-articular injection within 4 weeks prior to start of this study.
4 cases participated in other clinical study within the start of this study before 16 weeks.
5 cases with heart disease, liver dysfunction, kidney dysfunction, mental illness to be a clinical problem.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Deie |
Organization
Aichi Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1 Karimata, Yazako, Nagakute-shi, Aichi, Japan
TEL
0561-62-3311
snm@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Machiko Akao |
Organization
Aichi Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1 Karimata, Yazako, Nagakute-shi, Aichi, Japan
TEL
0561-62-3311
Homepage URL
akao@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
愛知医科大学病院 Aichi Medical University Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026050
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
