UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051851 |
|---|---|
| Receipt number | R000059165 |
| Scientific Title | Verification of thickness change rate and shear modulus of ankle soft tissue |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/02/19 12:23:15 |
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Basic information
Public title
Verification of thickness change rate and shear modulus of ankle soft tissue
Acronym
Verification of thickness change rate and shear modulus of ankle soft tissue
Scientific Title
Verification of thickness change rate and shear modulus of ankle soft tissue
Scientific Title:Acronym
Verification of thickness change rate and shear modulus of ankle soft tissue
Region
| Japan |
Condition
Condition
Open Reduction and Internal Fixation of Ankle Fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An anterior ankle impingement syndrome (AAIS) is reported to occur in a high percentage of patients after ankle labrum fracture surgery. However, the effects of anterior ankle soft tissue dynamics and tissue elasticity on AAIS are unknown. In this study, we used ultrasound to clarify the relationship between the rate of change in anterior ankle soft tissue thickness, shear modulus, and AAIS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation periods were 3 months and 6 months after surgery. The measurement positions were 10degree ankle plantar flexion and 0degree plantar dorsiflexion in the resting standing position. The tibialis anterior tendon, extensor hallucis longus tendon, and extensor hallucis longus tendon were visualized on long-axis images of the talar pulley and tibia using an ultrasound machine. Anterior soft tissue thickness was measured as the shortest distance from the convexity of the talar pulley to the tendon directly above it. The rate of change in anterior ankle soft tissue thickness was determined by dividing the value at 0degree ankle plantar dorsiflexion by the value at 10degree plantar flexion. The average shear modulus (kPa) was calculated using shear-wave elastography.
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
| 12 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are the ability to walk without load restrictions.
Key exclusion criteria
Dorsiflexion range of motion less than 0degree, history of neurological lesion, Chronic Ankle Instability, painful big toe under load, and FPI6 score of 6 or more for the medial foot and 0 or less for the external foot.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Osanami |
Organization
Keiyu Orthopaedic Hospital
Division name
Department of Rehabilitation
Zip code
3740013
Address
2267-1 Akouda-cho, Tatebayashi City, Gunma
TEL
0276499000
haruki.osanami140317@gmail.com
Public contact
Name of contact person
| 1st name | Mutsuaki |
| Middle name | |
| Last name | Edama |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
Shimami-cho1398, Kita-ku, Niigata City, Niigata
TEL
081252574450
Homepage URL
edama@nuhw.ac.jp
Sponsor or person
Institute
Keiyu Orthopaedic Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Keiyu Orthopaedic Hospital
Address
2267-1 Akouda-cho, Tatebayashi City, Gunma
Tel
0276499000
haruki.osanami140317@gmail.com
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 | 09 | 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
20
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
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study included 24 patients who had undergone open repair and fixation for ankle fractures (AO classification A and B) between May 2022 and March 2023. Inclusion criterion was the ability to walk without load restriction. Exclusion criteria were dorsiflexion range of motion less than 0degree, history of neurological lesions, Chronic Ankle Instability,hallux valgus with pain during weight bearing,and FPI6 score of 6 or higher or 0 or lower for clubfoot and clubfoot,respectively. Twenty subjects who finally met the criteria were included in the study. The healthy group consisted of 20 age- and sex-matched subjects. The healthy group was defined as those without neurological or orthopedic diseases. The evaluation periods were 3 months and 6 months postoperatively.
Management information
Registered date
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059165
