UMIN-CTR Clinical Trial

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
Email	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
Email	michi-ya@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042050