THR Performance & Assessment version 1.0
Research type
Research Study
Full title
A prospective randomised controlled study assessing the impact of simulation training in primary total hip replacement (THR).
IRAS ID
270167
Contact name
Jonathan Rees
Contact email
Sponsor organisation
University of Oxford/Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Research Summary
This study is focused upon assessing and optimising surgeon’s performance during, and patient outcomes following, 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 during a THR, or the outcome of patients after their THR. We also aim to define an ‘expert’ standard in performing a primary elective THR, and also determine if operative surgeon performance metrics are correlated with surgical experience, or patient outcomes.
The surgeon participants in this study will be divided into 2 groups. 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 (StR’s). The intervention to be tested is the simulation-based training. This will be delivered over a 4-week period in a supervised non-clinical setting to a randomised sub-group of 50% of the StR's enrolled into this study.
The outcome measures will be surgeon-specific and patient-specific.The surgeon-specific outcome measures will be the objective motion-analysis metrics generated by validated and extensively used wireless elbow sensors; and subjective assessments of surgical trainee performance using validated and reliable forms of structured human grading. All patient-specific outcome measures (with the exception of a post-operative questionnaire) are routinely collected as part of the patients NHS clinical care. All patients will be asked to provide their written informed consent for the use of their data in this study.
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:
1) The StR’s who have undertaken additional simulation training versus those who have routine Deanery training.
2) The ‘Trainee’ group and the ‘Expert’ group. A sub-group analysis may be performed within the ‘Expert’ group to determine any differences between the Consultants and Fellows.Summary of Results
Why was the research needed?
Total hip replacement (THR) is a successful and common operation which orthopaedic surgical trainees must demonstrate competence in prior to completion of their training. Training orthopaedic surgeons to perform operations such as THR well requires the accumulation of knowledge, technical skills, operative experience, professional judgement, alongside sufficient supervision until competence is achieved. This process is time-consuming, costly, and susceptible to variations in the healthcare systems and environment in which surgeons are now trained. Simulation training is a recognised educational method to supplement traditional apprentice-style training. This research aimed to fill an important gap in knowledge regarding the potential benefits of simulation training on surgeon performance and patient outcomes following THR.What were the main research questions?
This research aimed to determine if additional simulation training can improve the operative performance in theatre of surgical trainees during a THR, and/or patient outcomes following THR. A further aim was to investigate the impact of surgeon experience on intra-operative performance and patient outcome measures following THR.Who participated in the study?
The surgeon participants recruited into this study were divided into three groups depending upon their grade. Consultant orthopaedic surgeons (consultants) represented the ‘expert’ group, senior orthopaedic arthroplasty fellows (fellows) represented the ‘intermediate’ group, and orthopaedic specialty trainees (StRs) represented the ‘novice’ group.The patient participants recruited into this study included adult patients with severe hip pain diagnosed with hip osteoarthritis and undergoing elective primary THR within either of the NHS recruitment hospitals and with their operation performed by a surgeon participant as lead surgeon.
What treatments or interventions did the participants receive?
The intervention tested in this study was a one-day intensive simulation-based training module which was delivered to a randomised sub-group of surgeon participants within the ‘novice’ group. Surgeon participants within the ‘intermediate’ and ‘expert’ groups did not receive any additional training.All patient participants underwent routine elective primary THR using the normal standard implants used by their named surgeon and hospital.
What were the outcome measures used in this study?
Surgeon-specific, patient-specific, and hospital outcome measures were recorded.The surgeon-specific outcome measures included the operative time to perform the THR operation, and a system that monitors the hand motion of the surgeons.
The patient-specific outcome measures involved using health questionnaires called patient reported outcome measures (PROMS). These included a general health score called the EQ-5D and a hip joint-specific Oxford Hip Score (OHS). These are completed by patients pre-operatively and at three months post-operatively. Post-operative x-ray analysis, blood loss during surgery, and the number of blood transfusions were also recorded.
The hospital outcome measures included the post-operative length of patient stay (LOS) and whether there were any re-operations or re-admissions within 30 days of the THR.
What were the results of the study?
A total of 23 surgeon and 220 patient participants were recruited into this study.Within the 23 surgeon participants, there were eight consultants who collectively performed a total of 76 THRs; eight fellows who collectively performed a total of 92 THRs; and seven StRs who collectively performed a total of 52 THRs.
Most patients were female (69.5%). The overall mean patient age was 67.8 years old, and mean body mass index (BMI) was 28.9kg/m2. The demographics of the patient participants in this study are representative of patients undergoing primary THR across the NHS in the UK.
There were differences in the objective surgeon performance measures between the experience levels of the surgeons. Notably consultants demonstrated faster operative times with less hand movement than both the fellows and the StRs. Otherwise, except for reduced length of hospital stay in consultant led operations, there were no other clinically significant differences between surgical experience and the patient and hospital outcome measures recorded in this study. These results suggest if the trainees were supervised, the longer operating time and more hand movements they used to complete the THR did not seem to effect patient outcomes. These findings support other published studies which have reported no significant difference in complications and outcomes for patients undergoing THR operations performed by supervised trainee surgeons when compared to consultants.
There were also no significant differences in the surgeon, patient, or hospital outcome measures in the sub-group of StRs who underwent additional simulation training in comparison to StRs who had routine training only. While this might suggest that additional simulation training did not improve the operative performance of the trainee surgeons, this part of the study included a relatively small group of StRs with a wide range of operative experience in THR.
How has this study helped patients and researchers?
Organisations and individuals responsible for delivering surgical training can use the results of this study to maximise the operative experience of trainees during clinical placements, ensure adequate intra-operative supervision is in place, and consider using objective metrics for assessing trainee performance, competence, and progression through a training program. The study findings provide a useful benchmark for in-training performance assessment and to develop targeted strategies for future improvements in THR training.Although the impact of simulation training on surgeon-specific performance measures in this study was not obviously beneficial, the study was impacted by the COVID 19 pandemic and the number or trainee surgeons was small, meaning a future larger study would be needed to fully assess whether additional simulation training improves patient outcomes after THR.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0492
Date of REC Opinion
25 Oct 2019
REC opinion
Further Information Favourable Opinion