UMIN-CTR Clinical Trial

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
Email	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
Email	kosukega@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052953