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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031602
Receipt No. R000035942
Scientific Title A pilot study of a simple navigation system for Total Hip Arthroplasty in the lateral position using augmented reality technology
Date of disclosure of the study information 2018/03/06
Last modified on 2018/03/06

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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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