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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
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Research case data
Registered date File name