UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040167 |
|---|---|
| Receipt number | R000045796 |
| Scientific Title | In vivo kinematic analysis of hindfoot joint using bi-plane fluoroscopy |
| Date of disclosure of the study information | 2020/04/16 |
| Last modified on | 2025/05/19 19:51:07 |
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Basic information
Public title
In vivo kinematic analysis of hindfoot joint using bi-plane fluoroscopy
Acronym
In vivo kinematic analysis of hindfoot
Scientific Title
In vivo kinematic analysis of hindfoot joint using bi-plane fluoroscopy
Scientific Title:Acronym
In vivo kinematic analysis of hindfoot
Region
| Japan |
Condition
Condition
Osteoarthritis of ankle, avascular necrosis of the talus, talus fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the three-dimensional kinematics of the hindfoot joint with 3D-2D model registration techniques using fluoroscopic images.
Basic objectives2
Others
Basic objectives -Others
Kinematics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The range of motion and kinematic pattern of the hindfoot joint during dorsiflexion plantarflexion activities
Key secondary outcomes
Range of motion of hindfoot joints by manual examination
SAFE-Q
Radiographic measurements
Implant size
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Two groups are set: patients who have undergone total ankle arthroplasty (patient group) and healthy individuals who have no history of ankle disease (healthy group).
Patient group
1) Patients who have undergone total ankle arthroplasty at Chiba University Hospital, followed up at our outpatient clinic, and more than 6 months have passed since surgery
2) Patients who are over 20 years old at the time of obtaining consent
3) Patients who have received sufficient explanation for participation in this study, and who have fully understood and consented to the document by their own will.
Healthy group
4) Those who have no history of disease on the target foot
5) Those who are 20 years of age or older when obtaining consent
6) A person who has received sufficient explanation for participation in this study, and who has obtained sufficient written consent from the person's free will.
Key exclusion criteria
Persons who falls under any of the following conditions are not included.
Patient group
1) Patients who have difficulty walking alone
2) Patients who are judged inappropriate by the study investigator or the study coordinator for conducting this study safely
Healthy group
3) Those who have limited range of motion or instability of the ankle joint, as revealed by an orthopedic surgeon
4) Those who have abnormalities such as ostheoarthritic changes in the ankle radiograph
5) Those who are judged inappropriate by the study investigator or the study coordinator for conducting this study safely
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Chiba University Hospital
Division name
Orthopedics
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-226-2117
y-satoshi@mvb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Mikami |
Organization
Chiba University Hospital
Division name
Orthopedics
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-226-2117
Homepage URL
deepdish20002000@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology(MEXT), Japan
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
Chiba University Hospital, Clinical Research Center
Address
1-8-1, Inohana, Chuo-ku, Chiba
Tel
043-226-2734
prc-jim@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 16 | 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
| 2019 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 05 | Month | 13 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 13 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2020 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045796
