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 UMIN000035123
Receipt No. R000036890
Scientific Title Investigation of kinematics of anterior cruciate ligament difficient knee and meniscus difficient knee using 2D-3D registration technique.
Date of disclosure of the study information 2018/12/12
Last modified on 2018/12/03

* 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 Investigation of kinematics of anterior cruciate ligament difficient knee and meniscus difficient knee using 2D-3D registration technique.
Acronym Kinematics of ACL difficient knee and meniscus difficient knee.
Scientific Title Investigation of kinematics of anterior cruciate ligament difficient knee and meniscus difficient knee using 2D-3D registration technique.
Scientific Title:Acronym Kinematics of ACL difficient knee and meniscus difficient knee.
Region
Japan

Condition
Condition Anterior cruciate ligament (ACL) difficient 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 knee and meniscus difficient knee, a
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 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 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.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Patient group
1) ACL or meniscus diffiency diagnosed by MRI
2) Scheduled for ACL reconstuction or meniscus surgery in our hospital.
3) age; >=20, =<60

Normal knee group
1) age; >=20, =<40
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 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Taketomi
Organization Tokyo University
Division name Department of Orthopaedic surgery
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email takeos-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Yamagami
Organization Tokyo University
Division name Department of Orthopaedic surgery
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email yamagami-tky@umin.ac.jp

Sponsor
Institute Tokyo University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 24 Day
Last follow-up date
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
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.