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Clinical Trials/NCT02777333
NCT02777333
Completed
Not Applicable

Simulation-based Arthroscopic Surgery Study

University of Oxford1 site in 1 country30 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroscopy Training
Sponsor
University of Oxford
Enrollment
30
Locations
1
Primary Endpoint
Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
July 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

Time Frame: 3 months

Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.

Secondary Outcomes

  • Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
  • Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
  • Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
  • Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
  • Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
  • Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
  • Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
  • Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre(3 months)
  • Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
  • Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
  • Motion Analysis Parameters During Simulation(3 months)
  • Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging)(3 months)
  • Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre(3 months)
  • Feasibility of Additional Simulation Training(3 months)

Study Sites (1)

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