UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040097 |
|---|---|
| Receipt number | R000045716 |
| Scientific Title | Effect of flexion contracture on preoperative planning in high tibial osteotomy for knee osteoarthritis -Simulation using three-dimensional computed tomography of healthy volunteer's lower leg- |
| Date of disclosure of the study information | 2020/04/20 |
| Last modified on | 2021/04/19 13:30:16 |
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Basic information
Public title
Effect of flexion contracture on preoperative planning in high tibial osteotomy for knee osteoarthritis
-Simulation using three-dimensional computed tomography of healthy volunteer's lower leg-
Acronym
Effect of flexion contracture on preoperative planning in high tibial osteotomy
Scientific Title
Effect of flexion contracture on preoperative planning in high tibial osteotomy for knee osteoarthritis
-Simulation using three-dimensional computed tomography of healthy volunteer's lower leg-
Scientific Title:Acronym
Effect of flexion contracture on preoperative planning in high tibial osteotomy
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the planning errors in high tibial osteotomy due to knee flexion contracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
To clarify the errors in planned correction angle of high tibial osteotomy depending on the knee flexion contracture
Key secondary outcomes
Analysis of the changes in the parameters required for preoperative planning of high tibial osteotomy depending on the simulalted angle of the knee flection cntgacture
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
3C-CT of lower leg in knee full-extension.
The estimated CT dose index is 2.4mGy.
Interventions/Control_2
3D-CTs of lower leg which simulate flexion contracture in three different flexion angles.The estimated CT dose index is 2.4mGy per one scanning.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The persons who have no pain/dysfunction/deformity in their knees.
Key exclusion criteria
The persons who have some pain/dysfunction/deformity in their knees.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Matsumoto |
Organization
Harue Hospital
Division name
Department of radiology
Zip code
919-0476
Address
65-7 Haribara Harue-cho Sakai-shi,Fukui,Japan
TEL
0776-51-0029
rihabiri@harue-hp.org
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Matsumoto |
Organization
Harue Hospital
Division name
Department of radiology
Zip code
919-0476
Address
65-7 Haribara Harue-cho Sakai-shi,fukui,Japan
TEL
0776-51-0029
Homepage URL
toratamako@nifty.com
Sponsor or person
Institute
Harue Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Harue hospital Ethical review committie
Address
65-7 Haribara Harue-cho Sakai-shi Fukui,Japan
Tel
0776-51-0029
rihabiri@harue-hp.org
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
| 2020 | Year | 04 | Month | 20 | 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
10
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
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 07 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045716
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/25 | 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
