UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum
Acronym	The usefulness of navigation system in TOA
Scientific Title	Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum
Scientific Title:Acronym	The usefulness of navigation system in TOA
Region	Japan

Condition
Condition	Osteoarthritis secondary to hip dysplasia
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the usefulness of CT-based navigation system in transposition osteotomy of acetabulum by comparing the accuracy of the osteotomy and the clinical results with those of the conventional method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the difference between the preoperative planning and the actual osteotomy line.
Key secondary outcomes	To evaluate the difference in three-dimensional acetabular coverage of the femoral head between postoperative CT and preoperative planning. To evaluate physical activity and hip function preoperatively and at 1-year postoperatively.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	transposition osteotomy of acetabulum in conventional method
Interventions/Control_2	transposition osteotomy of acetabulum using CT-based navigation system
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	16 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age: 16 to 60 years-old 2) Male and Female 3) Patients with the ability of consent and writing. If a patient is under 20 years-old, his/her patients with the ability of consent and writing. 4) Patients who can visit hospital as scheduled during the research period
Key exclusion criteria	1) Patients with immature bone structure 2) Suspicious patients with metal allergy 3) Pregnant patients, pregnant suspicious patients, or patients who hope for pregnancy 4) Patients with the disease which can affect consent or evaluation of the study, including dementia, schizophrenia, depression, panic disorder, or generalized anxiety disorder 5) Patients who doctors judged unsuitable for the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yasuharu Middle name Last name Nakashima
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code	8128582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	0926425488
Email	yasunaka@ortho.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Goro Middle name Last name Motomura
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code	8128582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	0926425488
Homepage URL
Email	goromoto@ortho.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JPN

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

IRB Contact (For public release)
Organization	Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Hospital
Address	3-1-1, Maidashi, Higashi-ku
Tel	0926425082
Email	byskenkyu@jimu.kyushu-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	2020 Year 05 Month 01 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 03 Month 31 Day
Date of IRB	2020 Year 03 Month 31 Day
Anticipated trial start date	2020 Year 05 Month 01 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	2020 Year 04 Month 06 Day
Last modified on	2021 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045663

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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