UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021573 |
|---|---|
| Receipt number | 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 00:59:17 |
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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
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
jm-asokoji@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023755
