UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032126
Receipt number R000036654
Scientific Title Clinical study in the quantitative evaluation of rotatory stability using the mulrtiple axes sensor in the anterior cruciate ligament injury of the knee joint
Date of disclosure of the study information 2018/04/06
Last modified on 2020/10/08 08:40:56

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Basic information

Public title

Clinical study in the quantitative evaluation of rotatory stability using the mulrtiple axes sensor in the anterior cruciate ligament injury of the knee joint

Acronym

The quantitative evaluation of rotatory stability in the ACL-injured knee

Scientific Title

Clinical study in the quantitative evaluation of rotatory stability using the mulrtiple axes sensor in the anterior cruciate ligament injury of the knee joint

Scientific Title:Acronym

The quantitative evaluation of rotatory stability in the ACL-injured knee

Region

Japan


Condition

Condition

ACL injury of the knee joint

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate quantitatively of the rotatory atbility using the multiplke axes sensor in the ACL-injured kenn joint

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the rotatory atbility in the kenn joint

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with

1.ACL-injured unilateral knee and normal contralateral knee
2.indication for the ACL reconstructive suregry

Key exclusion criteria

Patients with

1. a concomitantmeniscal injury needed resection
2. other ligament injuries more than grade 2

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Eiichi
Middle name
Last name Nakamura

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Orthopaedic Suregery

Zip code

860-8556

Address

1-1-1, Honjyo, Chuo-ku, Kumamoto-City

TEL

096-373-5226

Email

h@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Eiichi
Middle name
Last name Nakamura

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Orthopaedic Suregery

Zip code

860-8556

Address

1-1-1, Honjyo, Chuo-ku, Kumamoto-City

TEL

096-373-5226

Homepage URL


Email

h@kumamoto-u.ac.jp


Sponsor or person

Institute

Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Department of Orthopaedic Suregery, Faculty of Life Sciences, Kumamoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Faculty of Life Sciences, Kumamoto University

Address

1-1-1, Honjyo, Chuo-ku, Kumamoto-City

Tel

096-373-5657

Email

ski-shien@jimu.kumamoto-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

2018 Year 04 Month 06 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

2017 Year 09 Month 19 Day

Date of IRB

2019 Year 04 Month 23 Day

Anticipated trial start date

2017 Year 09 Month 19 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

under examination


Management information

Registered date

2018 Year 04 Month 06 Day

Last modified on

2020 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036654


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name