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Completed

NCT Number: NCT04267172

Total Hip Replacement Performance & Assessment

This research study is focused upon assessing and optimising surgeon's performance during, and patient outcomes following, primary total hip replacement (THR) surgery. The primary research question is to determine if additional simulation training can improve the intra-operative performance of surgical trainees (Residents) during a THR, or the outcome of patients after their THR. The investigators will aim to define an 'expert' standard in performing a primary elective THR, which may be used as a benchmark when assessing surgical trainee performance; and also determine if operative surgeon performance metrics during a THR are correlated with surgical experience, or patient outcomes.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Botnar Research Centre

Oxford, Oxfordshire, OX3 7HE, United Kingdom

About this study

The surgeon participants in this study will be divided into 2 groups depending upon their position and seniority. The 'Expert' group will be composed of Consultant Orthopaedic Surgeons and Senior Fellows, and the 'Trainee' group will be composed of Trauma & Orthopaedic Specialty Registrars (Residents) on clinical placements in Adult Arthroplasty.

The intervention to be tested is the simulation-based training and cognitive learning package. This will be delivered for 1-2 hours per week over a 4-week period in a supervised non-clinical setting to a randomised sub-group of 50% of the Surgical Trainees enrolled into this study. Surgeon participants within the Expert/Fellow comparator group will not undergo any interventions.

The outcome measures will be surgeon-specific and patient-specific. These outcome measures for the 'Trainee' group will commence following completion of the simulation training (if applicable), whereas they can commence immediately following study approval for the 'Expert' group. The surgeon-specific outcome measures will be the objective motion-analysis metrics generated by validated and extensively used wireless sensors placed on the elbows of surgeons under their sterile gowns during the operation; and subjective assessments of surgical trainee performance using validated and reliable forms of structured human grading. Patient-specific outcome measures will be collected for a pre-determined number of patients who have undergone a primary elective THR by any of the surgeon participants in this study. All patient participants will be asked to provide their written informed consent for the use of their data in this study. The patient-specific outcome measures include: pre- and post-operative blood tests and radiograph (X-ray) analysis; the incidence of blood transfusions and any other peri-operative complications; the in-patient length of stay; and two patient-reported outcome measure (PROMs) questionnaires, namely the Oxford Hip Score (OHS) and EQ-5D.

Statistical analysis will be performed on the data collected, specifically aiming to identify any significant differences in either surgeon performance metrics, or patient outcome measures between:

  • The Surgical Trainees who have undertaken additional simulation training versus those who have routine training.
  • The 'Trainee' group and the 'Expert' group. A sub-group analysis may be performed within the 'Expert' group also to determine any differences between the Consultants and Fellows.

In summary, this novel research will use validated methodology and routinely collected patient outcome measures in order to determine the impact of simulation training on surgical trainee performance and patient outcomes following a primary elective THR, and also help to benchmark an expert level of performance in this commonly performed and highly effective operation. The results of this study will hopefully help in shaping the future of orthopaedic surgical training and assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients diagnosed with primary hip osteoarthritis who have been listed for elective primary Total Hip Replacement within the United Kingdoms National Health Service.
  • Total Hip Replacement performed by a surgeon participant as lead surgeon.

Exclusion criteria

  • Patients with complex hip pathology (e.g. previous trauma, hip dysplasia, infection).
  • Patients who have had previous surgery on their affected hip.

Treatment and study plan

Surgical simulation training in primary Total Hip Arthroplasty

Behavioral

The simulation-based and cognitive learning package will be delivered to a randomised sub-group of 50% of the Surgical Residents recruited into this study. This will be delivered in a supervised non-clinical setting within a dedicated University-owned simulation laboratory over a 4-week period for between 1 to 2 hours per week, over 3 to 4 consecutive but separate six-month placements.

No intervention: Surgical Resident Control Group

Other

Control Group

No Intervention: Consultant and Fellow Comparator Group

Other

Comparator Group

Primary outcomes

  1. Surgeon Participant Intra-operative Motion Analysis

    Time frame: Intra-operatively (single patient participant)

    Total number of surgeon hand movements obtained from elbow worn wireless motion sensors for each operation performed by the recruited surgeon participant as lead surgeon.

  2. Surgeon Participant Intra-operative Timings

    Time frame: Intra-operatively (single patient participant)

    Total time taken by each surgeon participant per step of the total hip replacement for each operation performed as lead surgeon.

  3. Surgical Trainee Global Rating Scale (GRS)

    Time frame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.

    A subjective human grading assessment of surgical performance rated on a scale of 7-35 with a higher score indicating a better surgical performance. GRS only performed for group 1a and 1b (i.e. Residents). Expert group did not have GRS collected.

  4. Percent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating.

    Time frame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.

    A subjective human grading assessment of surgical performance. Rated on a 5 point scale, with a higher score indicating a more competently performed procedure. OSATS only performed for group 1a and 1b (i.e. Residents). Expert group did not have OSATS collected.

Secondary outcomes

  1. Post-operative Patient X-ray

    Time frame: Assessment performed post-operatively within 8 weeks following procedure for each patient participant.

    Post-operative X-ray analysis for component orientation for each patient recruited into this study whose operation was performed by a recruited surgeon participant as lead surgeon.

  2. Patient Blood Loss.

    Time frame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.

    Estimated on-table blood loss (OTBL) for each patient participant whose operation performed by the recruited surgeon participant as lead surgeon.

    This figure was calculated by subtracting the total volume of intra-operative irrigation fluid used from the total volume of fluid in the suction canister in addition to weighing the surgical swabs.

  3. Number of Participants Requiring a Blood Transfusion.

    Time frame: Assessment performed per single patient participant during in-patient stay up to 14 days following operation.

    The number of units of packed red blood cells transfused for each patient participant (if applicable).

  4. Patient Hospital Length of Stay

    Time frame: From post-operation through to hospital discharge.

    Length of stay (total days) for each patient recruited into this study.

  5. Oxford Hip Score

    Time frame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively

    A joint-specific patient-reported outcome measure (PROM) to be assessed pre- and post-operatively. This is a 12 item questionnaire scored on a scale of 0-48, with a higher score representing better joint function. The change in score is presented and is defined as the value of the later time point (3-4 months post-operatively) minus the value at the earlier time point (pre-operatively).

  6. EQ-5D

    Time frame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively.

    A general patient-reported outcome measure (PROM) to be assessed pre- and post-operatively. The EQ-5D is comprised of 5 short questions each rated on a scale of 1-5 (25 points in total), with a higher score indicating a higher quality of life, and a visual analogue scale (EQ VAS) from 0-100, with a higher score indicating better health. The change in score is presented and is defined as the value of the later time point (3-4 months post-operatively) minus the value at the earlier time point (pre-operatively).

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Buckinghamshire Healthcare NHS Trust
  • Oxford University Hospitals NHS Trust

Registry information

Official study title

A Prospective Randomised Controlled Study Assessing the Impact of Simulation Training in Primary Total Hip Replacement (THR).

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2020
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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