Knee Arthroscopy SkillsASTORNCT02216448
Arthroscopy Simulator Training vs OR Training Knee
A study testing Training knee simulator and OR Training in people with Knee Arthroscopy Skills, run by Sheba Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroscopy Skills
- What is being tested?
- Training knee simulator and OR Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Orthopedic residents
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Knee Arthroscopy Skills
- Being tested
- Training knee simulator, OR Training
- Keywords
- Arthroscopy skills, Knee, Virtual reality, Simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training knee simulatorOther
Training in a lab on a virtual reality knee arthroscopy simulator
OR TrainingOther
Training on diagnostic knee arthroscopy in the OR
| Study group | Role | What they receive |
|---|---|---|
| simulator training | Other | Training knee simulator in Lab Receives: Other: Training knee simulator |
| OR training | Other | Training in the OR - 2 knee arthroscopies. Receives: Other: OR Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global rating scale
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.
Measured: completion of training
Secondary outcomes (1)
simulator parameters
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.
Measured: Completion of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Technical problems with simulator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroscopy SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Dan Prat MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216448
- Sponsor's protocol ID
- SHEBA-14-1236-DP-CTIL
- Acronym
- ASTOR
- Status last verified
- Apr 2018
- First submitted
- 9 Jul 2014
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Arthroscopic Simulator Training Versus Operating Room Training in Diagnostic Knee Arthroscopy for Residents With Basic Arthroscopic Skills
- ClinicalTrials.gov ID
- NCT02216448
- Acronym / sponsor ID
- ASTOR / SHEBA-14-1236-DP-CTIL
- Conditions
- Knee Arthroscopy Skills
- Keywords
- Arthroscopy skills, Knee, Virtual reality, Simulator
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical problems with simulator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simulator training | Other | Other: Training knee simulatorTraining knee simulator in Lab |
| OR training | Other | Other: OR TrainingTraining in the OR - 2 knee arthroscopies. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Orthopedic residents
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training knee simulatorTraining in a lab on a virtual reality knee arthroscopy simulator | Other | simulator training |
| OR TrainingTraining on diagnostic knee arthroscopy in the OR | Other | OR training |
Primary outcome
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.
1 secondary outcome
simulator parameters
Time frame: Completion of training
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
Related trials for Knee Arthroscopy Skills
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training knee simulator and OR Training in people with Knee Arthroscopy Skills, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global rating scale (time frame: completion of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.