UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035123 |
|---|---|
| Receipt number | R000036890 |
| Scientific Title | Investigation of kinematics of anterior cruciate ligament difficient/reconstructed knee and meniscus difficient knee using 2D-3D registration technique. |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2023/12/11 08:38:47 |
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Basic information
Public title
Investigation of kinematics of anterior cruciate ligament difficient/reconstructed knee and meniscus difficient knee using 2D-3D registration technique.
Acronym
Kinematics of ACL difficient/reconstructed knee and meniscus difficient knee.
Scientific Title
Investigation of kinematics of anterior cruciate ligament difficient/reconstructed knee and meniscus difficient knee using 2D-3D registration technique.
Scientific Title:Acronym
Kinematics of ACL difficient/reconstructed knee and meniscus difficient knee.
Region
| Japan |
Condition
Condition
Anterior cruciate ligament (ACL) difficient knee, ACL reconstructed knee and meniscus difficient knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the kinematics of ACL difficient or reconstructed knee and meniscus difficient knee
Basic objectives2
Others
Basic objectives -Others
To clarify the mechanism of development of knee arthritis after ACL or meniscus injury by comparing the kinematics of ACL difficient/reconstucted knee and meniscus difficient knee with the kinematics of normal knee.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The kinematics of ACL difficient/reconstructed knee, meniscus difficient knee and normal knee investigated by means of 2D-3D registration technique.
Key secondary 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
Prevention
Type of intervention
| Other |
Interventions/Control_1
The target groups undergo fluoroscopy test of the affected knees, where they are instructed to perform several daily living activites such as stairs climbing and squatting. They also undergo computed tomography (CT) scan of their affecte extremeties. The range of CT scan is from the hip joint to the anlke joint by 1 mm slice. MRIs of normal knees groups are additionally obtained.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient group(ACL dificient or meniscus difficient knee)
1) ACL or meniscus diffiency diagnosed by MRI
2) Scheduled for ACL reconstuction or meniscus surgery in our hospital.
3) Age; >=18, =<60
Patient group (ACL reconstructed knee)
1) Scheduled for arthroscopic surgery after ACL reconstruction in our hospital
2) Age; >=18, =<60
Normal knee group
1) age; >=18, =<60
Key exclusion criteria
Patient group
1) Existing osteoarthritis (Kellgren-Lawrence grade 2 or worse)
2) Ligament difficiency other than ACL that is necessary to be treated by surgery
3) Cartilage damage that is necessary to be treated by surgery
4) Past history of osteotomy of the affected knee
5) Systematic inflammatory condition such as connective tissue disorder
6) Females with signs of precnancy
7) Lactating females
Normal knee group
1) Existing osteoarthritis (Kellgren-Lawrence grade 2 or worse)
2) Persistent knee pain
3) Past history of knee srugery
4) Systematic inflammatory condition such as connective tissue disorder
5) Any other abnormal clinical findings of the knee
6) Females with signs of precnancy
7) Lactating females
Target sample size
205
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Taketomi |
Organization
The University of Tokyo
Division name
Department of Orthopaedic surgery
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-3815-5411
takeos-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Yamagami |
Organization
The University of Tokyo
Division name
Department of Orthopaedic surgery
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yamagami-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Scholarship donation
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
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo)
Address
Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2018 | Year | 12 | Month | 12 | 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
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | 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
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036890
