UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060085 |
|---|---|
| Receipt number | R000068716 |
| Scientific Title | Validity of Fluoroscopic Methods Along the Transsyndesmotic Axis for Syndesmosis Injury: A Cadaveric Study |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/15 13:07:01 |
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Basic information
Public title
Validity of Fluoroscopic Methods Along the Transsyndesmotic Axis for Syndesmosis Injury: A Cadaveric Study
Acronym
Validity of Fluoroscopic Methods for Syndesmosis Injury
Scientific Title
Validity of Fluoroscopic Methods Along the Transsyndesmotic Axis for Syndesmosis Injury: A Cadaveric Study
Scientific Title:Acronym
Validity of Fluoroscopic Methods for Syndesmosis Injury using Cadaver
Region
| Japan |
Condition
Condition
Syndesmotic injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the fixation of syndesmosis injury associated with ankle fracture, it is necessary to align along the transsyndesmotic (TS) axis. Clamp techniques for the tibiofibular joint along the TS axis include the center-center (CC), talar dome lateral (TL), and incisura tangent (IT) methods. However, it remains unclear whether clamp placement along the TS axis is feasible even under fluoroscopy and whether metal artifacts from fracture fixation have any impact. The purpose of this study is to clarify the differences from the TS axis using three methods under fluoroscopy on cadaver, and to compare the differences between the TS axis before and after metal implantation for each method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences between the axes of the three clamping methods and the TS axis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A cadaver donated with consent to the anatomy program of our university.
Key exclusion criteria
The osteoarthritis of the ankle, joint destruction, trauma, or a history of surgery.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Division name
Orthopediacs
Zip code
263-8522
Address
1-33 Yayoicho, Inage-ku, Chiba-shi, Chiba
TEL
043-226-2117
y-satoshi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Nakajima |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Division name
Orthopediacs
Zip code
260-8677
Address
1-8-1 inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432227171
Homepage URL
h.nakaji.0828@gmail.com
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
No
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
Chiba university
Address
1-8-1 inohana, Chuo-ku, Chiba-shi, Chiba
Tel
0432227171
inohana-koho@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
千葉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068716
