Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-22 @ 3:54 PM
Study NCT ID:
NCT02752451
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2016-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cigar Box Arthroscopy: A Study of Non-Anatomic Arthroscopy Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2016-04-23', 'studyFirstSubmitQcDate': '2016-04-23', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate in reaching a level of minimum proficiency', 'timeFrame': '1 hour', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of attempts to reach minimum proficiency', 'timeFrame': '1 Hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Simulation Training']}, 'descriptionModule': {'briefSummary': 'Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy skills after receiving prior training with different simulation systems.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First or Second year medical student with no prior arthroscopy or laparoscopy training.\n\nExclusion Criteria:\n\n* Having previously received education in arthroscopy or laparoscopy or handled these instruments.'}, 'identificationModule': {'nctId': 'NCT02752451', 'acronym': 'CBA', 'briefTitle': 'Cigar Box Arthroscopy: A Study of Non-Anatomic Arthroscopy Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Cigar Box Arthroscopy: A Randomized Controlled Trial Validates Non-Anatomic Simulation Training of Novice Arthroscopy Skills', 'orgStudyIdInfo': {'id': '1410543185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CO', 'description': '8 subjects who did not undergo arthroscopy simulation training prior to assessment on cadaveric specimens. These served as controls.', 'interventionNames': ['Other: Pre-assesment education']}, {'type': 'EXPERIMENTAL', 'label': 'CBAT', 'description': '8 Subjects who received 4 hours of simulation training on the Cigar Box Arthroscopy Trainer. They then underwent assessment on cadaveric specimens.', 'interventionNames': ['Other: Non-Anatomic Arthroscopy Simulation', 'Other: Pre-assesment education']}, {'type': 'EXPERIMENTAL', 'label': 'AKAT', 'description': '8 Subjects who received 4 hours of simulation training on the Anatomic Knee Arthroscopy Trainer. They then underwent assessment on cadaveric specimens.', 'interventionNames': ['Other: Anatomic Arthroscopy Simulation', 'Other: Pre-assesment education']}], 'interventions': [{'name': 'Non-Anatomic Arthroscopy Simulation', 'type': 'OTHER', 'description': 'Knee arthroscopy training using Cigar Box Arthroscopy Trainer', 'armGroupLabels': ['CBAT']}, {'name': 'Anatomic Arthroscopy Simulation', 'type': 'OTHER', 'description': 'Knee arthroscopy training using Anatomic Knee Arthroscopy Trainer', 'armGroupLabels': ['AKAT']}, {'name': 'Pre-assesment education', 'type': 'OTHER', 'description': 'Reading material and lecture with only still images about performing diagnostic knee arthroscopy', 'armGroupLabels': ['AKAT', 'CBAT', 'CO']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}