Clinical trial NCT04267172: Total Hip Replacement Performance & Assessment
Official title: A Prospective Randomised Controlled Study Assessing the Impact of Simulation Training in Primary Total Hip Replacement (THR).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Buckinghamshire Healthcare NHS Trust
name: Oxford University Hospitals NHS Trust
First posted: 2020-02-12
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 Residents enrolled into this study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. The Surgical Trainees who have undertaken additional simulation training versus those who have routine training.
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgeon Participant Intra-operative Motion Analysis
timeFrame: Intra-operatively (single patient participant)
measure: Surgeon Participant Intra-operative Timings
timeFrame: Intra-operatively (single patient participant)
measure: Surgical Trainee Global Rating Scale (GRS)
timeFrame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.
measure: Percent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating.
timeFrame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.
Secondary outcomes:
measure: Post-operative Patient X-ray
timeFrame: Assessment performed post-operatively within 8 weeks following procedure for each patient participant.
measure: Patient Blood Loss.
timeFrame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.
measure: Number of Participants Requiring a Blood Transfusion.
timeFrame: Assessment performed per single patient participant during in-patient stay up to 14 days following operation.
measure: Patient Hospital Length of Stay
timeFrame: From post-operation through to hospital discharge.
measure: Oxford Hip Score
timeFrame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively
measure: EQ-5D
timeFrame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Botnar Research Centre
state: Oxfordshire
Study officials:
References: