NCT02752451

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
Last Updated

August 23, 2024

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

April 23, 2016

Last Update Submit

August 21, 2024

Conditions

Simulation Training

Outcome Measures

Primary Outcomes (1)

  • Success rate in reaching a level of minimum proficiency

    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.

    1 hour

Secondary Outcomes (1)

  • Number of attempts to reach minimum proficiency

    1 Hour

Study Arms (3)

CO

OTHER

8 subjects who did not undergo arthroscopy simulation training prior to assessment on cadaveric specimens. These served as controls.

Other: Pre-assesment education

CBAT

EXPERIMENTAL

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 SimulationOther: Pre-assesment education

AKAT

EXPERIMENTAL

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 SimulationOther: Pre-assesment education

Interventions

Non-Anatomic Arthroscopy SimulationOTHER

Knee arthroscopy training using Cigar Box Arthroscopy Trainer

CBAT
Anatomic Arthroscopy SimulationOTHER

Knee arthroscopy training using Anatomic Knee Arthroscopy Trainer

AKAT
Pre-assesment educationOTHER

Reading material and lecture with only still images about performing diagnostic knee arthroscopy

AKATCBATCO

Eligibility Criteria

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

You may qualify if:

  • First or Second year medical student with no prior arthroscopy or laparoscopy training.

You may not qualify if:

  • Having previously received education in arthroscopy or laparoscopy or handled these instruments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2016

First Posted

April 27, 2016

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 23, 2024

Record last verified: 2016-06