UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study of a simple navigation system for Total Hip Arthroplasty in the lateral position using augmented reality technology
Acronym	A pilot study of a simple navigation system for Total Hip Arthroplasty in the lateral position using augmented reality technology
Scientific Title	A pilot study of a simple navigation system for Total Hip Arthroplasty in the lateral position using augmented reality technology
Scientific Title:Acronym	A pilot study of a simple navigation system for Total Hip Arthroplasty in the lateral position using augmented reality technology
Region	Japan

Condition
Condition	Hip joint disease scheduled for total hip arthroplasty Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture, rapidly destructive coxopathy, subchondral insufficiency fracture of the femoral head.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effecacy and safety of THA using a simple navigation system using AR technology for patients scheduled THA in the lateral position
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Accuracy of Implant Placement using X-ray and CT at 3 months postoperative (Absolute value error between intraoperative measured value and postoperative measured value)
Key secondary outcomes	Using CT at 3 months after surgery, -Cup installation angle and differences from 3-dimensional preoperative plan (adiographic inclination (RI) and radiographic anteversion (RA)) -Accuracy of leg extension and femoral neck cut level(Absolute value error between intraoperative measured value and postoperative measured value)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Set the target angle in advance, and install the cup using (A)angle goniometer. After installing the cup, Measure installation angle by using (B)simple navigation system using AR technology
Interventions/Control_2	Set the target angle in advance, and install the cup using (A)simple navigation system using AR technology. After installing the cup, Measure installation angle by using (B)angle goniometer.
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 who are scheduled to undergo THA with hip joint disease. (2) 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 the past in this study (2) Patients judged by the principal investigator to be inappropriate as subjects
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Ogawa
Organization	Nissan Tamagawa Hospital
Division name	Department of Orthopaedic Surgery
Zip code
Address	4-8-1 Seta, Setagaya, Tokyo
TEL	03-3700-1151
Email	wscww899@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Ogawa
Organization	Nissan Tamagawa Hospital
Division name	Department of Orthopaedic Surgery
Zip code
Address	4-8-1 Seta, Setagaya, Tokyo
TEL	03-3700-1151
Homepage URL
Email	wscww899@yahoo.co.jp

Sponsor
Institute	Nissan Tamagawa Hospital
Institute
Department

Funding Source
Organization	Nissan Tamagawa Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 06 Day
Last modified on	2018 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035942

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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