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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041847
Receipt No. R000047771
Scientific Title Intervention study for the accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by Zed HIP 3D planning software on CT based images
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/19

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Basic information
Public title The accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by 3D planning software on CT based images
Acronym The accuracy of the cup positioning in total hip arthroplasty with the patients specific guide
Scientific Title Intervention study for the accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by Zed HIP 3D planning software on CT based images
Scientific Title:Acronym Intervention study for the accuracy of the cup positioning with the patient specific guide
Region
Japan

Condition
Condition osteoarthritis of the hip
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by Zed HIP 3D planning software on CT based images
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The postoperative insertion angles of the cups
Key secondary outcomes Dislocation rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 the accuracy of the cup positioning in total hip arthroplasty (THA) with the patient specific guide made by Zed HIP 3D planning software on CT based images (40 hips)
Interventions/Control_2 the accuracy of the cup positioning in THA with the computer navigation technique on CT based images (40 hips)
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. secondary osteoarthritis due to femoral neck fracture, developmental dysplasia of the hip, rheumatoid arthritis and osteonecrosis of the femoral head
2. primary THA
3. in case of patients more than 20 years old
4. in case of patients who can voluntarily signed the agreement form
5. in case of patients who can continually receive a medical examination

Key exclusion criteria 1. In case of patients with a high risk of developing bacterial and fungal infections
2. In case of patients without the thickness of a bone sufficient for placing the implant
3. In case of patients with excessive deformation of the femoral bone
4. In case of patients who is suffering from dementia and cannot be evaluated by questionnaire.
5. In case of patients who is or may be pregnant
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Imai
Organization Ehime University
Division name Department of Bone and Joint Surgery
Zip code 791-0295
Address Shitsukawa, Toon, Ehime, Japan
TEL 0899605343
Email hiroimai@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Imai
Organization Ehime University Graduate School of Medicine
Division name Department of Bone and Joint Surgery
Zip code 791-0295
Address Shitsukawa, Toon, Ehime, Japan
TEL 0899605343
Homepage URL
Email hiroimai@m.ehime-u.ac.jp

Sponsor
Institute Department of Bone and Joint Surgery
Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Bone and Joint Surgery
Ehime University Graduate School of Medicine
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 Ehime University Graduate School of Medicine
Address Shitsukawa, Toon, Ehime, 791-0295 Japan
Tel 0899605343
Email orthop@m.ehime-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 愛媛大学医学部付属病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2020 Year 10 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 05 Day
Date of IRB
2020 Year 09 Month 14 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 Year 10 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 09 Month 19 Day
Last modified on
2020 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047771

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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