UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of a simple navigation system for total knee arthroplasty using augmented reality technology
Title of the study (Brief title)	A pilot study of a simple navigation system for total knee arthroplasty using augmented reality technology
Region	Japan

Condition
Condition	Patients with knee joint disease who are scheduled to undergo total knee arthroplasty(TKA) (osteoarthritis, rheumatoid arthritis, knee osteonecrosis).
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of TKA using mix-augmented reality technology in patients with knee joint disease who are scheduled to undergo TKA.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference between 3D pre-operative planning and post-operative implantation (by tibial component, internal and external rotation).
Key secondary outcomes	Difference between 3D pre-operative planning and post-operative implantation (by other than tibial component, internal and external rotation). Adverse event. Device deficiency.

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 TKA
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) Patients with knee joint disease (osteoarthritis, rheumatoid arthritis, knee osteonecrosis). (2) Patients who are scheduled to undergo TKA. (3) Patients aged 20 years or older at the time of acquiring consent. (4) Document consent can be obtained by the patient's free will, after receiving sufficient explanation for the participation of this study, after understanding.
Key exclusion criteria	(1) Patients who have been registered in this study in the past. (2) Patients with or suspected to have Creutzfeldt-Jakob disease. (3) Patients judged by the principal investigator to be inappropriate as subjects.
Target sample size	3

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	2018 Year 06 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 20 Day
Anticipated trial start date	2018 Year 06 Month 20 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	2018 Year 06 Month 06 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035964