UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031602 |
|---|---|
| Receipt number | 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 12:40:11 |
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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
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
wscww899@yahoo.co.jp
Sponsor or person
Institute
Nissan Tamagawa Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035942
