UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063616 |
|---|---|
| Receipt number | R000072806 |
| Scientific Title | Reduction of Syndesmotic Diastasis Associated With Ankle Fractures: Validation of a Novel Fluoroscopy-Guided Technique |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/13 08:05:12 |
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Basic information
Public title
Reduction of Syndesmotic Diastasis Associated With Ankle Fractures: Validation of a Novel Fluoroscopy-Guided Technique
Acronym
Reduction of Syndesmotic Diastasis Associated With Ankle Fractures: Validation of a Novel Fluoroscopy-Guided Technique
Scientific Title
Reduction of Syndesmotic Diastasis Associated With Ankle Fractures: Validation of a Novel Fluoroscopy-Guided Technique
Scientific Title:Acronym
Reduction of Syndesmotic Diastasis Associated With Ankle Fractures: Validation of a Novel Fluoroscopy-Guided Technique
Region
| Japan |
Condition
Condition
Patients who underwent ankle CT for foot or ankle disorders
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quantify and compare the angular deviations between the syndesmotic clamping directions determined using three fluoroscopic methods and the transsyndesmotic axis.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The angular difference between the transsyndesmotic axis and the screw insertion trajectory determined using each fluoroscopic method on axial CT images.
Key secondary outcomes
The distance between the points where the transsyndesmotic axis and the screw insertion trajectory determined using each fluoroscopic method intersect the medial tibial cortex on axial CT images.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who visited the Foot and Ankle Department at Chiba University Hospital between June 2019 and October 2023.
2. Patients who underwent ankle CT.
Key exclusion criteria
1. Ankle osteoarthritis classified as Tanaka-Takakura stage 2 or higher.
2. A current ankle fracture or a history of ankle fracture.
3. Bone destruction due to a tumor or inflammatory disease.
4. Obvious ankle deformity due to a paralytic condition or other causes.
5. Obvious deformity of the distal tibiofibular joint on axial or coronal CT images.
6. CT slice thickness >1 mm.
7. Ankle plantarflexion >20 degrees at the time of CT acquisition.
8. Age <18 years.
9. Patients who opted out of the study through the publicly available study information.
10. Patients otherwise deemed ineligible by the principal investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Department of Orthopaedic Surgery, Graduate School of Medical and Pharmaceutical Sciences, Chiba University
Division name
Orthopediacs
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi
TEL
0432227171
y-satoshi@faculty.chiba-u.jp
Public contact
Name of contact person
| 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
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi
TEL
0432227171
Homepage URL
y-satoshi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Hirofumi Nakajima
Funding Source
Organization
Chiba University
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
Chiba University
Address
1-8-1 inohana, Chuo-ku, Chiba-shi
Tel
0432227171
y-satoshi@faculty.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
| 2026 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
43
Results
Mean interaxis angles relative to the TS were -0.5, 6.3, and -1.8 degrees for the IT, CC, and TL methods, respectively. Angles were greater with CC than with IT or TL (P < .001). With IT, angles did not differ significantly between anteverted (-0.1 degrees) and retroverted (-1.0 degrees) incisurae (P = .15). With CC and TL, angles were greater in retroverted than in anteverted incisurae.
Results date posted
| 2026 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included individuals who underwent CT scanning to assess foot and ankle disease at our hospital from June 2019 to October 2023.
Participant flow
We excluded patients with (1) Tanaka-Takakura stage 2 or higher ankle osteoarthritis, (2) a history of ankle fracture or ongoing ankle fracture, (3) bone destruction because of inflammatory disease or a tumor, (4) deformity due to paralytic disease, (5) CT slice thickness exceeding 1 mm, (6) ankle plantar flexion angle exceeding 20 degrees in CT images, and (7) age less than 18 years.
Adverse events
None
Outcome measures
Interaxis angle and interaxis distance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 11 | Month | 13 | Day |
Last modified on
| 2026 | 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=R000072806
