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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021573
Receipt No. R000023755
Scientific Title Proprioceptive function of anterior cruciate ligament in knee osteoarthritis
Date of disclosure of the study information 2016/03/23
Last modified on 2016/03/23

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Basic information
Public title Proprioceptive function of anterior cruciate ligament in knee osteoarthritis
Acronym Proprioceptive function of anterior cruciate ligament in knee osteoarthritis
Scientific Title Proprioceptive function of anterior cruciate ligament in knee osteoarthritis
Scientific Title:Acronym Proprioceptive function of anterior cruciate ligament in knee osteoarthritis
Region
Japan

Condition
Condition Knee osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify proprioceptive function of anterior cruciate ligament in knee osteoarthritis.
Basic objectives2 Others
Basic objectives -Others To identify relationship between somatosensory evoked potentials(SEP) and joint proprioception.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Somatosensory evoked potentials (SEP) in anterior cruciate ligaments of knee osteoarthritis.
Key secondary outcomes Relationship between SEP and joint proprioception.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Induction of SEP by mechanical or electrical stimulation in ACL during surgery for knee osteoarthritis.
Interventions/Control_2 Induction of SEP by mechanical or electrical stimulation in ACL during surgery for ACL intact patients.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who receive an operation for knee osteoarthritis.
Key exclusion criteria The past of epilepsy
Pacemaker user
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aso koji
Organization Kochi Medical School, Kochi University
Division name Department of Orthopedic Surgery
Zip code
Address Oko-cho Kohasu, Nankoku, Kochi
TEL 088-880-2386
Email jm-asokoji@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aso koji
Organization Kochi Medical School, Kochi University
Division name Department of Orthopedic Surgery
Zip code
Address Oko-cho Kohasu, Nankoku, Kochi
TEL 088-880-2386
Homepage URL
Email jm-asokoji@kochi-u.ac.jp

Sponsor
Institute Department of Orthopedic Surgery, Kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 高知大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 23 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
2016 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 23 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
2016 Year 03 Month 23 Day
Last modified on
2016 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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