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Proficiency Based Training in Surgery - Employing An Arthroscopic Bankart Repair

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ClinicalTrials.gov Identifier: NCT01921621
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
Arthroscopy Association of North America

Brief Summary:
This study examines in a prospective, randomized and blinded study design the impact of a proficiency based training methodology on the acquisition of arthroscopic surgical skills employing both a dry shoulder simulator model, and cadaver specimens for the demonstration of surgical skill proficiency.

Condition or disease Intervention/treatment Phase
Study Focus: Simulation and Proficiency Based Training Behavioral: Group B - Simulation Training Behavioral: Group C - Proficiency Based Progression Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Copernicus Initiative - The Study of Proficiency Based Training in Arthroscopic Surgery
Study Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
No Intervention: Group A
Control: Group of Orthopedic Residents who receive arthroscopic surgery training at the Orthopedic Learning Center during a standard week-end Resident Arthroscopic Training Course
Active Comparator: Group B - Simulation Training
Group B resident training includes the use of a dry model shoulder simulator for practicing the steps and avoiding the errors of an arthroscopic Bankart repair
Behavioral: Group B - Simulation Training
Group B resident training includes the use of a dry model shoulder simulator for practicing the steps and avoiding the errors of an arthroscopic Bankart repair

Experimental: Group C - Proficiency Based Progression
Group C - Proficiency Based Progression Group C residents must test to proficiency on the cognitive material contained in the orientation video, demonstrate arthroscopic knot tying proficiency to a pre-determined benchmark, and perform an arthroscopic Bankart repair on a dry shoulder simulator model to a pre-determined benchmark in order to progress in the training exercise
Behavioral: Group C - Proficiency Based Progression
Group C - Proficiency Based Progression Group C residents must test to proficiency on the cognitive material contained in the orientation video, demonstrate arthroscopic knot tying proficiency to a pre-determined benchmark, and perform an arthroscopic Bankart repair on a dry shoulder simulator model to a pre-determined benchmark in order to progress in the training exercise




Primary Outcome Measures :
  1. score on a validated assessment tool using a videotaped performance of an arthroscopic Bankart repair [ Time Frame: 9 months ]
    validated metrics for a reference arthroscopic Bankart repair include 45 steps and 77 potential errors of which 20 are "sentinel errors" (either the error could potentially lead to a significant compromise of the success of the procedure, or introduces significant iatrogenic damage).


Secondary Outcome Measures :
  1. time to complete an arthroscopic Bankart repair on a cadaver specimen [ Time Frame: 6 months ]
    videotape duration in minutes and seconds less the time period to create the Bankart lesion



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 4th and 5th year Orthopedic Residents

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921621


Locations
United States, Illinois
Orthopedic Learning Center
Chicago, Illinois, United States, 60018
Sponsors and Collaborators
Arthroscopy Association of North America
Investigators
Principal Investigator: Richard Angelo, M.D. Arthroscopy Association of North America
Study Chair: Richard Ryu, M.D. Arthroscopy Association of North America
Study Chair: Robert Pedowitz, M. D., PhD. Arthroscopy Association of North America
Study Director: Anthony G Gallagher, PhD., D.Sc School of Medicine, University College Cork, Ireland.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arthroscopy Association of North America
ClinicalTrials.gov Identifier: NCT01921621     History of Changes
Other Study ID Numbers: AANA Copernicus Bankart - 1
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

Keywords provided by Arthroscopy Association of North America:
proficiency based progression
surgical skill
metric validation
formative feedback
simulator model