UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035501 |
|---|---|
| Receipt number | R000039141 |
| Scientific Title | Associations between body measurements and knee symptoms in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2019/01/09 |
| Last modified on | 2022/07/13 19:56:17 |
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Basic information
Public title
Associations between body measurements and knee symptoms in patients with knee osteoarthritis
Acronym
Associations between body measurements and knee symptoms in patients with knee osteoarthritis
Scientific Title
Associations between body measurements and knee symptoms in patients with knee osteoarthritis
Scientific Title:Acronym
Associations between body measurements and knee symptoms in patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between body measurement value and symptoms of knee osteoarthritis.
Basic objectives2
Others
Basic objectives -Others
Analysis of relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain rating scale of Japanese Knee Osteoarthritis Measure (JKOM-pain), Physical measurement value
Key secondary outcomes
Base
Study type
Observational
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 50 to 80 years old
2 Patients with degenerative knee osteoarthritis according to diagnostic criteria of the American College of Rheumatology
3 Patient with Kellgren Lawrence (K / L) classification 2 or higher in standing frontal knee joint X-ray image
4 Patients who gained document consent by the free will
Key exclusion criteria
1 Patients who received treatment such as exercise therapy, intra-articular injection and oral / external administration of anti-inflammatory analgesics at other medical institutions within 4 weeks of the survey.
2 Patient who is undergoing surgical treatment on the knee or planned
3 Patients with diseases requiring of steroid drugs
4 Damage of articular cartilage due to apparent trauma, arthritis, etc. Patients with a history
5 patients with diagnosis of rheumatoid arthritis, gout, pseudogout, collagen disease
6 Patients with severe cardiac dysfunction and liver / kidney function disorder
7 Other person who research director is inappropriate as the research subject
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Shimura |
Organization
Minamikoshigaya Hospital
Division name
Department of Orthopeadic surgery
Zip code
Address
1-4-63 Minamikoshigaya, Koshigaya, Saitama
TEL
0489872811
shimura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Shimura |
Organization
Minamikoshigaya Hospital
Division name
Department of Orthopeadic surgery
Zip code
Address
1-4-63 Minamikoshigaya, Koshigaya, Saitama
TEL
0489872811
Homepage URL
shimura@juntendo.ac.jp
Sponsor or person
Institute
Minamikoshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Minamikoshigaya Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 09 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2019 | Year | 01 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039141
