UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032886 |
|---|---|
| Receipt number | R000035964 |
| Scientific Title | A pilot study of a simple navigation system for total knee arthroplasty using augmented reality technology |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2018/08/24 13:15:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot study of a simple navigation system for total knee arthroplasty using augmented reality technology
Acronym
A pilot study of a simple navigation system for total knee arthroplasty using augmented reality technology
Scientific Title
A pilot study of a simple navigation system for total knee arthroplasty using augmented reality technology
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Daihei Kida |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
TEL
052-951-1111
kidad@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daihei Kida |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
TEL
052-951-1111
Homepage URL
kidad@nnh.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
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)
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
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 |
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035964
