Simulation-based Arthroscopic Surgery Study

NCT02777333 | Completed Results

• 1 other identifier: MSD-IDREC-C1-2014-152
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthroscopy Training

Keywords

Simulation; Arthroscopy; Motion analysis

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months

Secondary Outcomes (14)

• Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre

  3 months

• 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

• Stationary Time of 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

Study Arms (2)

Simulation training

EXPERIMENTAL

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

Behavioral: Simulation training

Non-simulation/Routine training

NO INTERVENTION

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

Interventions

Simulation training BEHAVIORAL

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

Simulation training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to provide informed consent
• Previously completed higher surgical training programme

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

Limitations and Caveats

Some outcomes were not analysed as stated in the trial protocol as during the construct validation stage these were found to not correlate with performance

Results Point of Contact

• Title: Mr P Garfjeld Roberts
• Organization: University of Oxford

patrick.garfjeldroberts@ndorms.ox.ac.uk

01865 227374

Study Officials

• Jonathan L Rees, FRCS-Tr&Orth

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: May 10, 2016
• First Posted: May 19, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)