- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752451
Cigar Box Arthroscopy: A Study of Non-Anatomic Arthroscopy Training (CBA)
August 21, 2024 updated by: University of Arizona
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- First or Second year medical student with no prior arthroscopy or laparoscopy training.
Exclusion Criteria:
- Having previously received education in arthroscopy or laparoscopy or handled these instruments.
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: CO
8 subjects who did not undergo arthroscopy simulation training prior to assessment on cadaveric specimens.
These served as controls.
|
Reading material and lecture with only still images about performing diagnostic knee arthroscopy
|
|
Experimental: CBAT
8 Subjects who received 4 hours of simulation training on the Cigar Box Arthroscopy Trainer.
They then underwent assessment on cadaveric specimens.
|
Reading material and lecture with only still images about performing diagnostic knee arthroscopy
Knee arthroscopy training using Cigar Box Arthroscopy Trainer
|
|
Experimental: AKAT
8 Subjects who received 4 hours of simulation training on the Anatomic Knee Arthroscopy Trainer.
They then underwent assessment on cadaveric specimens.
|
Reading material and lecture with only still images about performing diagnostic knee arthroscopy
Knee arthroscopy training using Anatomic Knee Arthroscopy Trainer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of attempts to reach minimum proficiency
Time Frame: 1 Hour
|
1 Hour
|
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
March 1, 2015
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
April 23, 2016
First Submitted That Met QC Criteria
April 23, 2016
First Posted (Estimated)
April 27, 2016
Study Record Updates
Last Update Posted (Actual)
August 23, 2024
Last Update Submitted That Met QC Criteria
August 21, 2024
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 1410543185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.