UMIN-CTR Clinical Trial

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
Email	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
Email	katagiri.orj@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental Universit
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043459