UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006678 |
|---|---|
| Receipt number | 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 13:05:56 |
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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
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
Sponsor or person
Institute
Department of Orthopaedic Surgery, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007890
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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