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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006678
Receipt No. R000007890
Scientific Title Evaluation for validity of Shoulder Virtual Reality Arthroscopic Trainer (VRAT). - Training using VRAT can improve the surgical skill of shoulder arthroscopy ? -
Date of disclosure of the study information 2011/11/07
Last modified on 2018/11/12

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Basic information
Public title Evaluation for validity of Shoulder Virtual Reality Arthroscopic Trainer (VRAT).
- Training using VRAT can improve the surgical skill of shoulder arthroscopy ? -
Acronym Evaluation for validity of Shoulder Virtual Reality Arthroscopic Trainer (VRAT).
- Training using VRAT can improve the surgical skill of shoulder arthroscopy ?-
Scientific Title Evaluation for validity of Shoulder Virtual Reality Arthroscopic Trainer (VRAT).
- Training using VRAT can improve the surgical skill of shoulder arthroscopy ? -
Scientific Title:Acronym Evaluation for validity of Shoulder Virtual Reality Arthroscopic Trainer (VRAT).
- Training using VRAT can improve the surgical skill of shoulder arthroscopy ?-
Region
Japan

Condition
Condition Recurrent dislocation (subluxation) of the shoulder, Rotator cuff tear
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the validity of training using VRAT for surgical skill of shoulder arthroscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjects train basic skill of shoulder arthroscopic surgery using VRAT, and
we score them by technical grade.
Items of Evaluation are "time for task", "accuracy of scope operation", "accuracy of probing", "roughness of scope operation", "roughness of probing". From the scroe, we evaluate whether training using VRAT help improvement of real arthroscopy technique.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Subjects train 3 hours a week for 2 month (total about 25 hours) using VRAT.
VRAT is INSIGHT-Arthroscopy(TM) Version 5.4 GMV, Spain.

Interventions/Control_2 Subjects without VRAT training.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients undergone arthroscopic surgery for recurrent dislocation (subluxation) of the shoulder and rotator cuff tear.
Key exclusion criteria Exclude patients who have no abnormality, and patients who have different abnormalities from recurrent dislocation (subluxation) of the shoulder and rotator cuff tear.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Sakane
Organization University of Tsukuba
Division name Department of Orthopaedic Surgery
Zip code
Address 1-1-1 Tennodai Tsukuba Ibaraki ,305-8575 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tsukuba
Division name Tsukuba Critical Path Research and Education Integrated leading Center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Orthopaedic Surgery, University of Tsukuba
Institute
Department

Funding Source
Organization The Japanese Foundation For Research and Promotion of Endscopy
Organization
Division
Category of Funding Organization Non profit foundation
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
2011 Year 11 Month 07 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 Completed
Date of protocol fixation
2011 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 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
2011 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007890

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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