UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046409 |
|---|---|
| Receipt number | R000052953 |
| Scientific Title | Quantitative evaluation of hip joint instability using ultrasound images and examination of its relationship with acetabular labrum tear |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2022/06/21 09:50:35 |
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Basic information
Public title
Quantitative evaluation of hip joint instability using ultrasound images and examination of its relationship with acetabular labrum tear
Acronym
Quantitative evaluation of hip joint instability using ultrasound images and examination of its relationship with acetabular labrum tear
Scientific Title
Quantitative evaluation of hip joint instability using ultrasound images and examination of its relationship with acetabular labrum tear
Scientific Title:Acronym
Quantitative evaluation of hip joint instability using ultrasound images and examination of its relationship with acetabular labrum tear
Region
| Japan |
Condition
Condition
acetabular labral tears
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the amount of deviation of the head position with respect to the acetabulum using an ultrasound images during the microinstability test, and examine the factors that test positive in patients with acetabular labral tears.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological analysis of hip instability
Key secondary outcomes
Patient background, symptoms, imaging findings, microinstability test and physiotherapy evaluation of bilateral hip joints before intervention, 3 months and 6 months after treatment, range of motion of hip and knee joints, manual muscle strength examination, joint laxity test.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Intervention is performed before and 3 and 6 months after treatment. It takes an hour to perform an ultrasound examination.
Interventions/Control_2
Healthy adult , volunteers
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
Acetabular dysplasia, Femoroacetabular impingement (FAI), acetabular labrum tear
Key exclusion criteria
not taken MRI images,or osteoarthritis of Tonnis grade 2 or higher
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Ima |
| Middle name | |
| Last name | Kosukegawa |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo
TEL
+81-11-611-2111
kosukega@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Ima |
| Middle name | |
| Last name | Kosukegawa |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo
TEL
+81-11-611-2111
Homepage URL
kosukega@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
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
Sapporo Medical University School of Medicine
Address
S1 W16, Chuo-ku, Sapporo
Tel
+81-11-611-2111
irb_info@sapmed.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 | 12 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 14 | 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
Management information
Registered date
| 2021 | Year | 12 | Month | 18 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052953
