UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040307
Receipt No. R000045987
Scientific Title Quantitative assessment of biochemical health of grafted cartilage using T1rho mapping
Date of disclosure of the study information 2021/07/01
Last modified on 2020/05/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Quantitative assessment of biochemical health of grafted cartilage using T1rho mapping
Acronym Assessment of grafted cartilage using T1rho mapping
Scientific Title Quantitative assessment of biochemical health of grafted cartilage using T1rho mapping
Scientific Title:Acronym Assessment of grafted cartilage using T1rho mapping
Region
Japan

Condition
Condition Osteochondral lesion of the talus
Classification by specialty
Orthopedics Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To quantitatively assess, by means of T1q imaging, changes over time in the biochemical health of grafted cartilage after autologous osteochondral transplantation for osteochondral lesions of the talus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tirho values at 1 week, 3 months, 6 months, 12 months, and 24 months after syrgery
Key secondary outcomes X-ray findings and clinical outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 MR examinations at 1 week, 3 months, 6 months, 12 months, and 24 months after syrgery
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with osteochondral lesion
of the talus
2. Patient gave written informed consent
Key exclusion criteria 1. Patients with pacemakers
2. Patients with claustrophobia
3. Patients who are pregnant
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Haraguchi
Organization St. Marianna University Yokohama Seibu Hospital
Division name Department of Orthopaedic Surgery
Zip code 241-0811
Address 1197-1 Yasashicho, Asahi-ku, Yokohama, Kanagawa 241-0811
TEL 0453661111
Email naokihg@aol.com

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Haraguchi
Organization St. Marianna University Yokohama Seibu Hospital
Division name Department of Orthopaedic Surgery
Zip code 241-0811
Address 1197-1 Yasashicho, Asahi-ku, Yokohama, Kanagawa 241-0811
TEL 0453661111
Homepage URL
Email naokihg@aol.com

Sponsor
Institute St. Marianna University Yokohama Seibu Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 St. Marianna University Yokohama Seibu Hospital
Address 1197-1 Yasashicho, Asahi-ku, Yokohama, Kanagawa 241-0811
Tel 09057679613
Email naokihg@aol.com

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
2021 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2024 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
2020 Year 05 Month 04 Day
Last modified on
2020 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045987

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.