UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038130 |
|---|---|
| Receipt number | R000043459 |
| Scientific Title | Validation study of additional bone marrow stimulation procedures for meniscal sutures |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2019/09/27 10:43:36 |
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Basic information
Public title
Validation study of additional bone marrow stimulation procedures for meniscal sutures
Acronym
Validation study of additional bone marrow stimulation procedures for meniscal sutures
Scientific Title
Validation study of additional bone marrow stimulation procedures for meniscal sutures
Scientific Title:Acronym
Validation study of additional bone marrow stimulation procedures for meniscal sutures
Region
| Japan |
Condition
Condition
Meniscus injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of additional bone marrow stimulation procedures for meniscal sutures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Meniscus fusion rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
bone marrow stimulation
Interventions/Control_2
Control
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
| 12 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection policy: All patients undergoing meniscal sutures with meniscal injury on MRI
Gender: no restrictions
Age: No limit
Key exclusion criteria
Those who have contraindications for MRI, such as pacemakers and claustrophobia.
Anterior cruciate ligament dysfunction, posterior cruciate ligament dysfunction, medial collateral ligament failure, lateral collateral ligament failure
Others who are judged medically inappropriate.
Highly deformed knee
Those who cannot consent from the person due to dementia or a decline in consciousness level
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | HIROKI |
| Middle name | |
| Last name | KATAGIRI |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine, Graduate School of Medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5678
katagiri.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | HIROKI |
| Middle name | |
| Last name | HIROKI |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine, Graduate School of Medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5678
Homepage URL
katagiri.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental Universit
Institute
Department
Personal name
Funding Source
Organization
Japan Sports Medicine Association
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
0358034675
katagiri.orj@tmd.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
| 2023 | Year | 09 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 27 | Day |
Last modified on
| 2019 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043459
