Simulation TrainingCBANCT02752451
Cigar Box Arthroscopy: A Study of Non-Anatomic Arthroscopy Training
A study testing Non-Anatomic Arthroscopy Simulation, Anatomic Arthroscopy Simulation and Pre-assesment education in people with Simulation Training, run by University of Arizona.
Trial summary
Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy skills after receiving prior training with different simulation systems. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation Training
- What is being tested?
- Non-Anatomic Arthroscopy Simulation, Anatomic Arthroscopy Simulation and Pre-assesment education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First or Second year medical student with no prior arthroscopy or laparoscopy training.
Who cannot join
- Having previously received education in arthroscopy or laparoscopy or handled these instruments.
About this study
Official title: Cigar Box Arthroscopy: A Randomized Controlled Trial Validates Non-Anatomic Simulation Training of Novice Arthroscopy Skills
Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy skills after receiving prior training with different simulation systems.
Read the detailed description
A non-anatomic set of training modules utilizing cigar boxes was developed at our institution to instruct residents in the basics of knee arthroscopy. Twenty-four medical students with no prior arthroscopic or laparoscopic experience were enrolled as subjects. Sixteen subjects were randomized to participate in four hours of either the cigar box arthroscopy trainer (CBAT) or a previously validated anatomic knee arthroscopy trainer (AKAT). The remaining eight subjects served as controls (CO). All subjects underwent a one-hour formalized training session provided by our orthopaedic sports faculty. Subjects' skills were assessed by one of two faculty members through repeated attempts at performing a diagnostic knee arthroscopy on a cadaveric specimen. Objective scores were given using the Basic Arthroscopic Knee Skill Scoring System. Total cost differences were also calculated.
- Conditions
- Simulation Training
- Being tested
- Non-Anatomic Arthroscopy Simulation, Anatomic Arthroscopy Simulation, Pre-assesment education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Anatomic Arthroscopy SimulationOther
Knee arthroscopy training using Cigar Box Arthroscopy Trainer
Anatomic Arthroscopy SimulationOther
Knee arthroscopy training using Anatomic Knee Arthroscopy Trainer
Pre-assesment educationOther
Reading material and lecture with only still images about performing diagnostic knee arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| CO | Other | 8 subjects who did not undergo arthroscopy simulation training prior to assessment on cadaveric specimens. These served as controls. Receives: Other: Pre-assesment education |
| CBAT | Experimental | 8 Subjects who received 4 hours of simulation training on the Cigar Box Arthroscopy Trainer. They then underwent assessment on cadaveric specimens. Receives: Other: Non-Anatomic Arthroscopy Simulation; Other: Pre-assesment education |
| AKAT | Experimental | 8 Subjects who received 4 hours of simulation training on the Anatomic Knee Arthroscopy Trainer. They then underwent assessment on cadaveric specimens. Receives: Other: Anatomic Arthroscopy Simulation; Other: Pre-assesment education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in reaching a level of minimum proficiency
Subjects were told to perform serial knee arthroscopic examinations on a cadaveric specimen over one hour. Evaluators used a validated objective scoring system to assess performance and which subjects were able to attain a level of minimum proficiency.
Measured: 1 hour
Secondary outcomes (1)
Number of attempts to reach minimum proficiency
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752451
- Sponsor's protocol ID
- 1410543185
- Acronym
- CBA
- Status last verified
- Jun 2016
- First submitted
- 23 Apr 2016
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cigar Box Arthroscopy: A Randomized Controlled Trial Validates Non-Anatomic Simulation Training of Novice Arthroscopy Skills
- ClinicalTrials.gov ID
- NCT02752451
- Acronym / sponsor ID
- CBA / 1410543185
- Conditions
- Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Apr 2016 (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.
Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy skills after receiving prior training with different simulation systems.
Detailed description
A non-anatomic set of training modules utilizing cigar boxes was developed at our institution to instruct residents in the basics of knee arthroscopy. Twenty-four medical students with no prior arthroscopic or laparoscopic experience were enrolled as subjects. Sixteen subjects were randomized to participate in four hours of either the cigar box arthroscopy trainer (CBAT) or a previously validated anatomic knee arthroscopy trainer (AKAT). The remaining eight subjects served as controls (CO). All subjects underwent a one-hour formalized training session provided by our orthopaedic sports faculty. Subjects' skills were assessed by one of two faculty members through repeated attempts at performing a diagnostic knee arthroscopy on a cadaveric specimen. Objective scores were given using the Basic Arthroscopic Knee Skill Scoring System. Total cost differences were also calculated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CO | Other | Other: Pre-assesment education8 subjects who did not undergo arthroscopy simulation training prior to assessment on cadaveric specimens. These served as controls. |
| CBAT | Experimental | Other: Non-Anatomic Arthroscopy Simulation, Other: Pre-assesment education8 Subjects who received 4 hours of simulation training on the Cigar Box Arthroscopy Trainer. They then underwent assessment on cadaveric specimens. |
| AKAT | Experimental | Other: Anatomic Arthroscopy Simulation, Other: Pre-assesment education8 Subjects who received 4 hours of simulation training on the Anatomic Knee Arthroscopy Trainer. They then underwent assessment on cadaveric specimens. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First or Second year medical student with no prior arthroscopy or laparoscopy training.
Key exclusion criteria (1 listed)
- Having previously received education in arthroscopy or laparoscopy or handled these instruments.
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 |
|---|---|---|
| Non-Anatomic Arthroscopy SimulationKnee arthroscopy training using Cigar Box Arthroscopy Trainer | Other | CBAT |
| Anatomic Arthroscopy SimulationKnee arthroscopy training using Anatomic Knee Arthroscopy Trainer | Other | AKAT |
| Pre-assesment educationReading material and lecture with only still images about performing diagnostic knee arthroscopy | Other | AKAT, CBAT, CO |
Primary outcome
Success rate in reaching a level of minimum proficiency
Time frame: 1 hour
Subjects were told to perform serial knee arthroscopic examinations on a cadaveric specimen over one hour. Evaluators used a validated objective scoring system to assess performance and which subjects were able to attain a level of minimum proficiency.
1 secondary outcome
Number of attempts to reach minimum proficiency
Time frame: 1 Hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Anatomic Arthroscopy Simulation, Anatomic Arthroscopy Simulation and Pre-assesment education in people with Simulation Training, run by University of Arizona.
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: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success rate in reaching a level of minimum proficiency (time frame: 1 hour). 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 Aug 2024.