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Cigar Box Arthroscopy: A Study of Non-Anatomic Arthroscopy Training (CBA)

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ClinicalTrials.gov Identifier: NCT02752451
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Rory Sandberg, University of Arizona

Brief Summary:
Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy skills after receiving prior training with different simulation systems.

Condition or disease Intervention/treatment Phase
Simulation Training Other: Non-Anatomic Arthroscopy Simulation Other: Anatomic Arthroscopy Simulation Other: Pre-assesment education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Cigar Box Arthroscopy: A Randomized Controlled Trial Validates Non-Anatomic Simulation Training of Novice Arthroscopy Skills
Study Start Date : March 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
CO
8 subjects who did not undergo arthroscopy simulation training prior to assessment on cadaveric specimens. These served as controls.
Other: Pre-assesment education
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.
Other: Non-Anatomic Arthroscopy Simulation
Knee arthroscopy training using Cigar Box Arthroscopy Trainer

Other: Pre-assesment education
Reading material and lecture with only still images about performing diagnostic knee arthroscopy

Experimental: AKAT
8 Subjects who received 4 hours of simulation training on the Anatomic Knee Arthroscopy Trainer. They then underwent assessment on cadaveric specimens.
Other: Anatomic Arthroscopy Simulation
Knee arthroscopy training using Anatomic Knee Arthroscopy Trainer

Other: Pre-assesment education
Reading material and lecture with only still images about performing diagnostic knee arthroscopy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of attempts to reach minimum proficiency [ Time Frame: 1 Hour ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Rory Sandberg, MD, University of Arizona
ClinicalTrials.gov Identifier: NCT02752451     History of Changes
Other Study ID Numbers: 1410543185
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided