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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040072
Receipt No. R000045663
Scientific Title Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum
Date of disclosure of the study information 2020/05/01
Last modified on 2021/04/09

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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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