UMIN-CTR Clinical Trial

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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