UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036898 |
|---|---|
| Receipt number | R000042050 |
| Scientific Title | A pilot study for the feasibility of elbow arthroscopy using augmented reality |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2021/05/06 09:21:40 |
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Basic information
Public title
A pilot study for the feasibility of elbow arthroscopy using augmented reality
Acronym
AR arthroscopy
Scientific Title
A pilot study for the feasibility of elbow arthroscopy using augmented reality
Scientific Title:Acronym
AR arthroscopy
Region
| Japan |
Condition
Condition
elbow osteoarthritis, tennis elbow
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In arthroscopic surgery, the structure within the joint can be observed on a monitor, but extra-articular tissue can not be observed. Therefore, important organs such as nerves present outside the joint capsule have not been confirmed by arthroscopy. Using information on nerves and bones from MRI images taken before surgery and superimposing them on the arthroscopic monitor, the operator can know the position of nerves, and it is expected to improve the safety of surgery. The purpose of this research is to use this system clinically and to create a real model from the obtained image information using a 3D printer and use it as a training system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy of position where nerve and bone image are superimposed
Key secondary outcomes
clinical results one year after arthroscopic surgery
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with elbow osteoarthritis or tennis elbow who are treated arthroscopically
Key exclusion criteria
patients who can not speak Japanese
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Hirata |
Organization
Nagoya University
Division name
Hand surgery
Zip code
466-8550
Address
65 Tsurumai-cho Showa-ku, Nagoya
TEL
564711935
h-hirata@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Nagoya University
Division name
Hand surgery
Zip code
466-8550
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
+81527442957
Homepage URL
michi-ya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C) 2019-2021
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65 tsurumai-cho, Showa-ku, Nagoya
Tel
0527412111
iga-shinsa@adm.nagoya-u.ac.jp
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
| 2019 | Year | 12 | Month | 31 | 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
| 2019 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After IRB approval this study will start.
Management information
Registered date
| 2019 | Year | 05 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042050
