Simulation-based Arthroscopic Surgery Study

NCT ID: NCT02777333

Last Updated: 2021-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-31

Brief Summary

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The purpose of this study is to determine whether simulation training improves the performance during arthroscopic surgery ('keyhole' surgery into a joint).

Detailed Description

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This single blinded randomised controlled study of junior orthopaedic trainees aims to assess whether the addition of simulation training improves arthroscopic technical skills performance of junior orthopaedic trainees during knee arthroscopy in the operating theatre compared to their usual clinical training programme. This will be assessed using objective motion analysis parameters recorded from wireless elbow-mounted motion sensors during surgery.

Conditions

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Arthroscopy Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Simulation training

Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme

Group Type EXPERIMENTAL

Simulation training

Intervention Type BEHAVIORAL

Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators

Non-simulation/Routine training

Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simulation training

Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study.
* Healthy adults, Male or Female, aged 18 years or above.
* Enrolled in Health Education Thames Valley/Oxford Deanery Training Programme in junior surgical training posts

Exclusion Criteria

* Unwilling or unable to provide informed consent
* Previously completed higher surgical training programme
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan L Rees, FRCS-Tr&Orth

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Nuffield Orthopaedic Centre

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MSD-IDREC-C1-2014-152

Identifier Type: -

Identifier Source: org_study_id

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