UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052777 |
|---|---|
| Receipt number | R000060224 |
| Scientific Title | A multicenter observational study of joint kinematics and implant alignment in total ankle arthroplasty |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/13 07:53:23 |
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Basic information
Public title
A multicenter observational study on joint kinematics and implant alignment of total ankle arthroplasty
Acronym
A multicenter study on joint kinematics of total ankle arthroplasty
Scientific Title
A multicenter observational study of joint kinematics and implant alignment in total ankle arthroplasty
Scientific Title:Acronym
A multicenter study on joint kinematics of total ankle arthroplasty
Region
| Japan |
Condition
Condition
Ankle osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify ankle rotational kinematics in patients after total ankle arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tibio-talar rotational joint angle in ankle neutral position
Key secondary outcomes
Tibio-talar range of motion from maximal dorsiflexion to plantarflexion
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have undergone total ankle arthroplasty at Chiba University Hospital or joint research institution at least 2 years postoperatively.
2) Patients in the age of 18 years or older.
3) Patients provided informed consent.
Key exclusion criteria
1) Patients who have undergone revision surgery
2) Patients unable to walk
3) Patients unsuitable for conducting this study safely.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Chiba University
Division name
Graduate School of Global and Transdisciplinary Studies
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
+81-43-226-2117
y-satoshi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Chiba University
Division name
Graduate School of Global and Transdisciplinary Studies
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
+81-43-226-2117
Homepage URL
y-satoshi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Research ethics committee of Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
+81-43-222-7171
hsp-kansaturinri@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
| 2023 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics, patient reported outcomes, radiography, and CT data will be recorded.
Management information
Registered date
| 2023 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060224
