UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of cup angle assisted by ACO guide
Title of the study (Brief title)	Cup angle analysis by ACO guide
Region	Japan

Condition
Condition	Neck fracture, Hip OA, Hip RA, Osteonecrosis of the hip joint
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In patients with femoral neck fracture or hip osteoarthritis or rheumatoid arthritis or idiopathic femoral head necrosis who will be judged to undergo total hip arthroplasty, the purpose of this study is to evaluate cup angle in 3D CT image, which was simulated preoperatively and implanted postoperatively by ACO guide.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of 3 dimensional angle of implanted cup after operation immediately
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Operation support operation 1 day
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	Eligible patients with inclusion criteria and without exclusion criteria described as below 1) Patients with hip osteoarthritis, rheumatoid arthritis, idiopathic osteonecrosis of the femoral head, which the researcher deemed application of total hip arthroplasty, will be the target diseases in this study. 2) Patients with primary total hip arthroplasty, using cementless cup. 3) Patients over 20 years old 4) Patient who signed informed consent form with patient's own voluntary intention. During the observation period, patients who intend to continue to participate in this study
Key exclusion criteria	Patients will be excluded as follow 1) Patients with infection 2) Patients with primary bone tumor or metastatic bone tumor who developed large bone defect to support the implant 3) Patients with surgical history such as osteotomy in the pelvis, with significant bone deformity 4) Patient who performs total hip arthroplasty in supine position 5) Patients who developed dementia and influence to obtain adequate evaluation 6) In patients with systemic disease, which affects the assessment 7) Pregnant patients, possible patients of pregnant 8) Patients whom the research director judged as noneligible
Target sample size	55

Research contact person
Name of lead principal investigator	Satoshi Nagoya
Organization	Sapporo Medical University
Division name	Dept. of Musculoskeletal Biomechanics and Surgical Development
Address	S1 W17 Chuo-Ku, Sapporo, Japan
TEL	011-611-2111(39200)
Email	nagoya@sapmed.ac.jp

Public contact
Name of contact person	Yukikko Yoshida
Organization	Sapporo Medical University
Division name	Department of Orthopedic Surgery
Address	S1 W16 Chuo-Ku, Sapporo, Japan
TEL	011-611-2111(33350)
Homepage URL
Email	y.yoshida@sapmed.ac.jp

Sponsor
Institute	Dept. of Musculoskeletal Biomechanics and Surgical Development Sapporo Medical University
Institute
Department

Funding Source
Organization	Japan MDM
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 13 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 29 Day
Last modified on	2017 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033536