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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

Tracking Information
First Submitted Date  ICMJE April 23, 2016
First Posted Date  ICMJE April 27, 2016
Last Update Posted Date June 3, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
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. Evaluatiors used a validated objective scoring system to assess performance and which subjects were able to attain a level of minimum proficiency.
Change History Complete list of historical versions of study NCT02752451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
Number of attempts to reach minimum proficiency [ Time Frame: 1 Hour ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cigar Box Arthroscopy: A Study of Non-Anatomic Arthroscopy Training
Official Title  ICMJE Cigar Box Arthroscopy: A Randomized Controlled Trial Validates Non-Anatomic Simulation Training of Novice Arthroscopy Skills
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Simulation Training
Intervention  ICMJE
  • Other: Non-Anatomic Arthroscopy Simulation
    Knee arthroscopy training using Cigar Box Arthroscopy Trainer
  • 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
Study Arms  ICMJE
  • CO
    8 subjects who did not undergo arthroscopy simulation training prior to assessment on cadaveric specimens. These served as controls.
    Intervention: Other: Pre-assesment education
  • Experimental: CBAT
    8 Subjects who received 4 hours of simulation training on the Cigar Box Arthroscopy Trainer. They then underwent assessment on cadaveric specimens.
    Interventions:
    • Other: Non-Anatomic Arthroscopy Simulation
    • Other: Pre-assesment education
  • Experimental: AKAT
    8 Subjects who received 4 hours of simulation training on the Anatomic Knee Arthroscopy Trainer. They then underwent assessment on cadaveric specimens.
    Interventions:
    • Other: Anatomic Arthroscopy Simulation
    • Other: Pre-assesment education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02752451
Other Study ID Numbers  ICMJE 1410543185
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rory Sandberg, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Arizona
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP