Clinical trial NCT02777333: Simulation-based Arthroscopic Surgery Study
Official title: Simulation-based Arthroscopic Surgery Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopy Training
Keywords: Simulation
Arthroscopy
Motion analysis
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
Secondary outcomes:
measure: Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
measure: Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
measure: Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
measure: Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
measure: Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
measure: Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
measure: Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre
timeFrame: 3 months
measure: Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
timeFrame: 3 months
measure: Motion Analysis Parameters During Simulation
timeFrame: 3 months
measure: Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging)
timeFrame: 3 months
measure: Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
timeFrame: 3 months
measure: Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
timeFrame: 3 months
measure: Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
timeFrame: 3 months
measure: Feasibility of Additional Simulation Training
timeFrame: 3 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Jonathan L Rees, FRCS-Tr&Orth
role: PRINCIPAL_INVESTIGATOR
References: