NCT01921621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

August 7, 2013

Last Update Submit

March 27, 2014

Conditions

Study Focus: Simulation and Proficiency Based Training

Keywords

proficiency based progressionsurgical skillmetric validationformative feedbacksimulator model

Outcome Measures

Primary Outcomes (1)

  • score on a validated assessment tool using a videotaped performance of an arthroscopic Bankart repair

    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).

    9 months

Secondary Outcomes (1)

  • time to complete an arthroscopic Bankart repair on a cadaver specimen

    6 months

Study Arms (3)

Group A

NO INTERVENTION

Control: Group of Orthopedic Residents who receive arthroscopic surgery training at the Orthopedic Learning Center during a standard week-end Resident Arthroscopic Training Course

Group B - Simulation Training

ACTIVE COMPARATOR

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 C - Proficiency Based Progression

EXPERIMENTAL

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

Interventions

Group B - Simulation TrainingBEHAVIORAL

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

Group B - Simulation Training
Group C - Proficiency Based ProgressionBEHAVIORAL

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

Group C - Proficiency Based Progression

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th and 5th year Orthopedic Residents

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Learning Center

Chicago, Illinois, 60018, United States

Location

Related Publications (2)

  • Angelo RL, Ryu RK, Pedowitz RA, Gallagher AG. The Bankart Performance Metrics Combined With a Cadaveric Shoulder Create a Precise and Accurate Assessment Tool for Measuring Surgeon Skill. Arthroscopy. 2015 Sep;31(9):1655-70. doi: 10.1016/j.arthro.2015.05.006. Epub 2015 Jul 31.

    PMID: 26238730DERIVED

  • Angelo RL, Pedowitz RA, Ryu RK, Gallagher AG. The Bankart Performance Metrics Combined With a Shoulder Model Simulator Create a Precise and Accurate Training Tool for Measuring Surgeon Skill. Arthroscopy. 2015 Sep;31(9):1639-54. doi: 10.1016/j.arthro.2015.04.092. Epub 2015 Jun 27.

    PMID: 26129726DERIVED

Study Officials

  • Richard Angelo, M.D.

    Arthroscopy Association of North America

    PRINCIPAL INVESTIGATOR

  • Richard Ryu, M.D.

    Arthroscopy Association of North America

    STUDY CHAIR

  • Robert Pedowitz, M. D., PhD.

    Arthroscopy Association of North America

    STUDY CHAIR

  • Anthony G Gallagher, PhD., D.Sc

    School of Medicine, University College Cork, Ireland.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations

US(1)