UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040301 |
|---|---|
| Receipt number | R000045978 |
| Scientific Title | T1rho mapping of articular cartilage after intraarticular fracture: a longitudinal evaluation |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2024/05/08 16:27:12 |
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Basic information
Public title
T1rho mapping of articular cartilage after intraarticular fracture: a longitudinal evaluation
Acronym
T1rho mapping of articular cartilage after intraarticular fracture
Scientific Title
T1rho mapping of articular cartilage after intraarticular fracture: a longitudinal evaluation
Scientific Title:Acronym
T1rho mapping of articular cartilage after intraarticular fracture
Region
| Japan |
Condition
Condition
Intraarticular fracture of the ankle
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively assess, by means of T1rho imaging, changes over time in the biochemical health of cartilage after intraarticular fracture of the ankle
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with ankle fracture or pilon fracture
2. Patient gave written informed consent
Key exclusion criteria
1. Open fracture cases
2. Patients with multiple injury
3. Patients with pacemakers
4. Patients with claustrophobia
5. 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
TEL
0453661111
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
TEL
0453661111
Homepage URL
naokihg@aol.com
Sponsor or person
Institute
St. Marianna University Yokohama Seibu Hospital
Institute
Department
Personal name
Funding Source
Organization
National Mutual Insurance Federation of Agricultural Cooperatives
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
Tel
0453661111
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
聖マリアンナ医科大学横浜市西部病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
20
Results
T1 rho values and safe-q at 6, 12, 24 months post op.
Results date posted
| 2024 | Year | 05 | Month | 08 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to Covid-19 disaster.
Date of the first journal publication of results
Baseline Characteristics
Patients who undertake OATS procedure.
Participant flow
MRI is performed preop and 2-3 days, 3 months, 6 months, 12 months, 24 months postop.
Adverse events
Pain during MRI.
Outcome measures
T1rho values of the ankle cartilage.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | 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 | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045978
