UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	comparative study of the measuring instrument for the improvement of the cup position in THA
Title of the study (Brief title)	comparative study of the measuring instrument for the improvement of the cup position in THA
Region	Japan

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

Objectives
Narrative objectives1	comparative study of the instrument of the cup positioner in THA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	verification of the cup position by measuring on post-op CT
Key secondary outcomes	clinical results

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	mobile navigation
Interventions/Control_2	cup mechanical navigator
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	osteoarthritis of the hip osteonecrosis of the hip femoral neck fracture
Key exclusion criteria	patients with internal medicine
Target sample size	80

Research contact person
Name of lead principal investigator	Kentaro Iwakiri
Organization	Shiraniwa Hospital
Division name	Orthopaedics
Address	6-10-1 Shiraniwadai Ikoma-city
TEL	0743-70-0022
Email	kenpiecekenpiece@yahoo.co.jp

Public contact
Name of contact person	Kentaro Iwakiri
Organization	Shiraniwa Hospital
Division name	Orthopaedics
Address	6-10-1 Shiraniwadai Ikoma-city
TEL	0743-70-0022
Homepage URL
Email	kenpiecekenpiece@yahoo.co.jp

Sponsor
Institute	Shiraniwa Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	2019 Year 02 Month 18 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 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	2019 Year 02 Month 18 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040917