UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054185 |
|---|---|
| Receipt number | R000061874 |
| Scientific Title | Evaluation of qualitative imaging techniques after autologous cultured chondrocyte implantation |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/04/18 12:30:53 |
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Basic information
Public title
Evaluation of qualitative imaging techniques after autologous cultured chondrocyte implantation
Acronym
Evaluation of qualitative imaging techniques after autologous cultured chondrocyte implantation
Scientific Title
Evaluation of qualitative imaging techniques after autologous cultured chondrocyte implantation
Scientific Title:Acronym
Evaluation of qualitative imaging techniques after autologous cultured chondrocyte implantation
Region
| Japan |
Condition
Condition
cartilage injury of knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effectiveness of qualitative MRI in transplanted tissue after Autologous cultured Chondrocyte Implantation for articular cartilage injury of knee joint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative time correlates with T1rho map and T2map values on qualitative MRI examination, qualitative MRI can detect the condition of transplanted tissue 0 to 20 years after autologous cultured chondrocyte implantation.
Key secondary outcomes
Morphological MRI images and MOCART score
Clinical scores VAS, koos score, Lysholm score, WOMAC
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Qualitative MRI will be performed on patients who have undergone autologous cultured chondrocyte transplantation for knee cartilage injury after 0-20 years between March 2017 and September 2019.
T1rho map and T2 map will be measured from the obtained images.
Morphological MRI images are taken under the same conditions.The MOCART score is calculated from the obtained images.
Clinical scores (Lysholm score, KOOS score, IKDC score, WOMAC score) are calculated under the same conditions.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
An autologous cultured chondrocyte transplantation was performed for a knee joint cartilage injury.
A postoperative qualitative MRI scan was performed.
Key exclusion criteria
Imaging tests with qualitative measurements could not be performed or the data were poor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Tadenuma |
Organization
Shimane University
Division name
Faculty of Medicine, department of Rehabilitation medicine
Zip code
693-8501
Address
Enya89-1, Izumo city, Shimane prefecture
TEL
0853-88-3047
tadenuma@med.shimmane-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Tadenuma |
Organization
Shimane University
Division name
Faculty of Medicine, department of Rehabilitation medicine
Zip code
693-8501
Address
Enya89-1, Izumo city, Shimane prefecture
TEL
0853-88-3047
Homepage URL
tadenuma@med.shimmane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
Enya89-1, Izumo city, Shimane prefecture
Tel
0853202515
kenkyu@med.shiamne-u.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
| 2024 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061874
