UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024618 |
|---|---|
| Receipt number | R000028322 |
| Scientific Title | The effect of lateral wedge insole on medial meniscus extrusion and knee adduction moment |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2025/11/04 10:50:22 |
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Basic information
Public title
The effect of lateral wedge insole on medial meniscus extrusion and knee adduction moment
Acronym
The effect of lateral wedge insole on medial meniscus extrusion
Scientific Title
The effect of lateral wedge insole on medial meniscus extrusion and knee adduction moment
Scientific Title:Acronym
The effect of lateral wedge insole on medial meniscus extrusion
Region
| Japan |
Condition
Condition
knee Osteoarthritis, Medial meniscus tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lateral wedge insole on medial meniscus extrusion and biomechanical factor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Medial meniscus extrusion
Key secondary outcomes
knee adduction moment, acceleration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
without lateral wedge insole
Interventions/Control_2
with lateral wedge insole
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants are defined by diagnosed with musculoskeletal diseases, including knee osteoarthritis. They are outpatients or pre-postoperatively hospitalized patients at Hiroshima University Hospital or Kagawa University Hospital.
The controls are any volunteers, including students aged 20 or more older, and staff at the University or the hospital in Hiroshima University.
Key exclusion criteria
Subjects were excluded if they had a history of surgical treatment, trauma, and neurological disorder.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Takahashi |
Organization
Health Sciences Major, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan
Division name
Biomedical and Health Sicences
Zip code
082-257-5457
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5555
mako2@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Ishii |
Organization
Health Sciences Major, Graduate School of Biomedical & Health Sciences, Hiroshima University
Division name
Bio-Environmental Adaptation Sciences
Zip code
082-257-5457
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5555
Homepage URL
s.h.iypt@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee for epidemiolody of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5907
iryo-sinsa@office.hiroshima-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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
Sixteen participants were recruited.
Adverse events
N/A
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028322
