UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043086 |
|---|---|
| Receipt number | R000049132 |
| Scientific Title | Evaluation of the anterior talofibular ligament by ultrasonography |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2023/07/26 10:36:54 |
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Basic information
Public title
Evaluation of the anterior talofibular ligament by ultrasonography
Acronym
Evaluation of the anterior talofibular ligament by ultrasonography
Scientific Title
Evaluation of the anterior talofibular ligament by ultrasonography
Scientific Title:Acronym
Evaluation of the anterior talofibular ligament by ultrasonography
Region
| Japan |
Condition
Condition
ankle sprain
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the ultrasonographic findings of the length of the anterior talofibular ligament (ATFL) under non-stressed conditions and that under stressed conditions in healthy subjects (including patients with no lower limb diseases). The stress in this study refers to the physical load applied to the ankle joint.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Length of the ATFL under unstressed, under manual maximum ankle inversion stress, and under manual anterior drawer stress.
Key secondary outcomes
1)Relationship between the length of ATFL and the sex, age and the foot size
2)Inter-rater reliability in ultrasonographic evaluation
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have received sufficient explanation for participation in this study and have given written informed consent of their own free will with full understanding.
(2) Patients who have no history of repetitive ankle sprain as a target group
(3) Patients who are less than 50 years old
Key exclusion criteria
(1) Patients with a history of recurrent ankle sprains
(2) Patients with acute ankle joint diseases (initial ankle sprain, ankle joint infection, etc.)
(3) Those with a history of surgery for the foot and ankle diseases
(4) Those who have been diagnosed with rheumatoid arthritis or osteoarthritis of the ankle.
(5) Those who are considered inappropriate for the participation to this study by the investigators
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of MIYAZAKI
Division name
Department of orthopaedic surgery, Faculty of medicine
Zip code
889-1692
Address
5200 KIHARA, KIYOTAKE, MIYAZAKI
TEL
0985-85-0986
chosa@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Yokoe |
Organization
University of MIYAZAKI
Division name
Department of orthopaedic surgery, Faculty of medicine
Zip code
889-1692
Address
5200 KIHARA, KIYOTAKE, MIYAZAKI
TEL
0985-85-0986
Homepage URL
takuji_yokoe@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of MIYAZAKI
Institute
Department
Personal name
Funding Source
Organization
University of MIYAZAKI
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
General Affairs Department, University of Miyazaki Hospital
Address
5200 KIHARA, KIYOTAKE, MIYAZAKI 889-1692, JAPAN
Tel
0985-85-9403
igakubu_kenkyu@med.miyazaki-u.ac.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
| 2021 | Year | 01 | Month | 22 | 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
| 2020 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following information at the time of the ultrasound examination should be investigated.
1) Basic information: age, sex, foot size, medical history of ankle joint disease, etc.
Clinical findings: pain, range of motion of the ankle joint
2) Clinical findings: pain, range of motion of the ankle joint 3) Evaluation of generalized joint laxity as reported by Beighton et al.
3) Evaluation of generalized joint laxity as reported by Beighton et al. Two orthopedic surgeons will evaluate the following findings for each examinee.
Measurement of the length of the ATFL under non-stress conditions
(2) Measurement of the length of the ATFL under maximal ankle inversion manual stress.
(3) Measurement of the length of the ATFL under manual anterior stress (anterior stress to the examinee's tibia).
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049132
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