UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Open-label, non-controlled study of patient specific femoral guide (PSG) for total hip arthroplasty (THA), linked with 3D surgical support software
Title of the study (Brief title)	Study of PSG for THA, linked with 3D surgical support software (Study of PSG for THA)
Region	Japan

Condition
Condition	Hip joint disease scheduled for total hip arthroplasty (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture)
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of efficacy and safety for patient specific guide, linked with 3D surgical support software on total hip arthroplasty
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defference of stem antetorsion (by neck axis)between 3D pre-operative planning and post-operative implantation.
Key secondary outcomes	Differences between 3D pre-operative planning and post-operative implantation in the following items. -Stem angle differences in antetorsion (by stem axis), varus / valgus, and flextion / extension. -Depth from center of stem. -Stem spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z ( axial)-axis. -Cup angle differences in radiographic inclination (RI) and radiographic anteversion (RA). -Cup spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z(axial)-axis. Leg length discrepancy. Adverse event.

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	Using patient specific guide linked with 3D surgical support software for total hip arthroplasty
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	(1) Age more than 20 years, at the time of acquiring consent (2) Document consent canbe obtained by the patient's free will, after receiving sufficient explanation for the participation of this study, after understanding
Key exclusion criteria	(1) Patients judged by the principal investigator to be inappropriate as subjects (2) Patients who have been registered in the past in this study (3) Patients with posterior pelvic inclination more than 20 degrees (4) Patients with or suspected to have Creutzfeldt-Jakob disease
Target sample size	23

Research contact person
Name of lead principal investigator	Daihei Kida
Organization	National Hospital Organization Nagoya Medical Center
Division name	Orthopedic Surgery and Rheumatology
Address	4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL	052-951-1111
Email	kidad@nnh.hosp.go.jp

Public contact
Name of contact person	Daihei Kida
Organization	National Hospital Organization Nagoya Medical Center
Division name	Orthopedic Surgery and Rheumatology
Address	4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL	052-951-1111
Homepage URL
Email	kidad@nnh.hosp.go.jp

Sponsor
Institute	National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Nagoya Medical Center
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	独立行政法人　国立病院機構 名古屋医療センター

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 18 Day
Anticipated trial start date	2017 Year 01 Month 24 Day
Last follow-up date	2017 Year 08 Month 08 Day
Date of closure to data entry	2017 Year 09 Month 06 Day
Date trial data considered complete	2017 Year 09 Month 13 Day
Date analysis concluded	2017 Year 09 Month 14 Day

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

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2017 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028122