- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02216448
Arthroscopy Simulator Training vs OR Training Knee (ASTOR)
April 19, 2018 updated by: Dr. Dan Prat MD, Sheba Medical Center
The Benefit of Arthroscopic Simulator Training Versus Operating Room Training in Diagnostic Knee Arthroscopy for Residents With Basic Arthroscopic Skills
The purpose of this study is to compare between two groups of residents with basic arthroscopic skills in diagnostic knee arthroscopy.
The first group will train on a knee arthroscopic simulator in a lab, and the second group will perform diagnostic knee arthroscopy in the operating room.
Both groups will be assessed by senior arthroscopy surgeon in the operating room based on selected competencies following the Global Rating System.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ramat Gan, Israel
- Sheba Tel Hashomer
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Orthopedic residents
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: simulator training
Training knee simulator in Lab
|
Training in a lab on a virtual reality knee arthroscopy simulator
|
|
Other: OR training
Training in the OR - 2 knee arthroscopies.
|
Training on diagnostic knee arthroscopy in the OR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global rating scale
Time Frame: completion of training
|
About 3 months will be needed for both study arms to complete the training in the arthroscopy lab and in the OR.
Then, both will be assessed by the global rating scale for arthroscopy.
|
completion of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
simulator parameters
Time Frame: Completion of training
|
Secondary outcome measures are technical parameters provided by the simulator for each trainee.
At the end of the training sessions, about 3 months from the beginning of the study, this parameters can be collected.
|
Completion of training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
July 9, 2014
First Submitted That Met QC Criteria
August 13, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Actual)
April 23, 2018
Last Update Submitted That Met QC Criteria
April 19, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SHEBA-14-1236-DP-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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