UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of navigation system and three-dimensional finite element analysis for hip surgery
Title of the study (Brief title)	Usefulness of navigation system and three-dimensional finite element analysis for hip surgery
Region	Japan

Condition
Condition	hip disease
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the accuracy and safety of the surgery using navigation system and stress changes due to hip surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The accuracy and safety of the surgery using navigation system and stress in the hip joint analyzed by finite element analysis.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	Surgical treatment with navigation.
Interventions/Control_2	Surgical treatment without navigation.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with surgical treatment (total hip arthroplasty or hip osteotomy) in the hip joint.
Key exclusion criteria	Informed consent was not obtained.
Target sample size	50

Research contact person
Name of lead principal investigator	Yutaka Inaba
Organization	Yokohama City University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	Fukuura 3-9, Kanazawaku, Yokohama
TEL	045-787-2800
Email	sle9999mds@yahoo.co.jp

Public contact
Name of contact person	Hiroyuki Ike
Organization	Yokohama City University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	Fukuura 3-9, Kanazawaku, Yokohama
TEL	045-787-2800
Homepage URL
Email	sle9999mds@yahoo.co.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Local Government
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	2018 Year 05 Month 24 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 05 Month 08 Day
Anticipated trial start date	2009 Year 05 Month 08 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 24 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037246