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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031875
Receipt No. R000036331
Scientific Title Analysis of accuracy of navigation system in total hip arthroplasty
Date of disclosure of the study information 2018/05/01
Last modified on 2020/03/28

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Basic information
Public title Analysis of accuracy of navigation system in total hip arthroplasty
Acronym Analysis of accuracy of navigation system in total hip arthroplasty
Scientific Title Analysis of accuracy of navigation system in total hip arthroplasty
Scientific Title:Acronym Analysis of accuracy of navigation system in total hip arthroplasty
Region
Japan

Condition
Condition Osteoarthritis of the hip, idiopathic necrosis of the femoral head, rheumatoid arthritis, femoral neck fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the accuracy of cup orientation in total hip arthroplasty using a CT-based navigation system and a portable navigation system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the accuracy of cup position in total hip arthroplasty between CT-based navigation and portable navigation.
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who satisfy all of the following criteria are targeted.
1) Patients with osteoarthritis of the hip with joint space narrowing, rheumatoid arthritis, idiopathic femoral head necrosis with femoral head collapse, femoral neck fracture.
2) Patients who are over 20 years of age at consent acquisition
3) After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
4) Inpatients
Key exclusion criteria Patients with any of the following will not be included in this study.
1) Patients with highly deformed ilium due to pelvic fracture, pelvic surgery, etc.
2) Women who may be pregnant or have a possibility of pregnancy
3) Lactating women
4) Patients who are deemed inappropriate by the researchers.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Tetsunaga
Organization Okayama University Hospital
Division name Department of Orthopaedics
Zip code 7008558
Address 2-5-1 Shikata-Cho Kitaku, Okayama, Japan
TEL 086-235-7273
Email tomonori_t31@yahoo.co.jp

Public contact
Name of contact person
1st name Tomonori
Middle name
Last name Tetsunaga
Organization Okayama University Hospital
Division name Department of Orthopaedics
Zip code 7008558
Address 2-5-1 Shikata-Cho Kitaku, Okayama, Japan
TEL 086-235-7273
Homepage URL
Email tomonori_t31@yahoo.co.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Okayama University
Address 2-5-1 Shikata-cho, Kitaku, Okayama, Japan
Tel 0862356938
Email tomonori_t31@yahoo.co.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
2018 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 50
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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 23 Day
Date of IRB
2018 Year 06 Month 11 Day
Anticipated trial start date
2018 Year 06 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information Tomonori Tetsunaga MD, PhD
Fepartment of Orthopaedics, Okayama University Hospital
2-5-1 Shikata-Cho Kitaku, Okayama, Japan
Tel: +81-86-235-7273
Fax: +81-86-225-9727

Management information
Registered date
2018 Year 03 Month 24 Day
Last modified on
2020 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036331

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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