UMIN-CTR Clinical Trial

Basic information
Public title	Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Acronym	Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Scientific Title	Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Scientific Title:Acronym	Patient reported outcome measures and quality of life assessment after rotational acetabular osteotomy
Region	Japan

Condition
Condition	Acetabular dysplasia
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the outcomes after Rotational acetabular osteotomy using patient-reported outcome measures and quality of life assessment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient-reported outcome measures( at the timing of more than 2 years after surgery): Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire (JHEQ) EQ-5D
Key secondary outcomes	X-ray film, CT, MRI Clinical outcomes: Harris hip score, JOA hip score Sport activity

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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who underwent rotational acetabular osteotomy(minimum of 2 years after surgery)
Key exclusion criteria	Patients who refuse to participate in this study Unsuitable for this study as evaluated by the physician-in-charge
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Enishi
Organization	Tokushima municipal hospital
Division name	Department of Rehabilitation Medicine
Zip code	7700812
Address	2-34 Kitajosanjima, Tokushima 7700812, Japan
TEL	0886225121
Email	tetsuya-e@umin.org

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Enishi
Organization	Tokushima Municipal Hospital
Division name	Department of Rehabilitation Medicine
Zip code	7700812
Address	2-34 Kitajosanjima, Tokushima 7700812, Japan
TEL	0886225121
Homepage URL
Email	tetsuya-e@umin.org

Sponsor
Institute	Department of Rehabilitation Medicine, Tokushima Municipal Hospital
Institute
Department

Funding Source
Organization	Tokushima Municipal Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokushima Municipal Hospital
Address	2-34 Kitajosanjima, Tokushima 7700812, Japan
Tel	0886225121
Email	tetsuya-e@umin.org

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	Tokushima Municipal Hospital

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 27 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	Completed
Date of protocol fixation	2019 Year 11 Month 29 Day
Date of IRB	2019 Year 11 Month 29 Day
Anticipated trial start date	2019 Year 11 Month 29 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Data will be obtained from medical record.

Management information
Registered date	2019 Year 12 Month 25 Day
Last modified on	2022 Year 06 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044458