Total Hip Replacement Performance & Assessment

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267172
• Other study ID #: 270167
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Behavioral:
• Surgical simulation training in primary Total Hip Arthroplasty
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.

Other:
• No intervention: Surgical Resident Control Group
Control Group
• No Intervention: Consultant and Fellow Comparator Group
Comparator Group

Locations

Country	Name	City	State
United Kingdom	Botnar Research Centre	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Buckinghamshire Healthcare NHS Trust, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon participant intra-operative motion analysis	Total number of surgeon hand movements obtained from elbow worn wireless motion sensors.	24 months
Primary	Surgeon participant intra-operative timings	Total time taken by each surgeon participant per step of the total hip replacement.	24 months
Primary	Surgical Trainee Global Rating Scale (GRS)	A subjective human grading assessment of surgical performance rated on a scale of 7-35 with a higher score indicating a better surgical performance.	24 months
Primary	Objective Structured Assessment of Technical Skills (OSATS)	A subjective human grading assessment of surgical performance. Rated on a 5 point scale, with a higher score indicating a more competently performed procedure.	24 months
Secondary	Post-operative patient X-ray	Post-operative X-ray analysis for component positioning, orientation, and quality of cementing for each patient recruited into this study.	24 months
Secondary	Patient blood loss.	Pre- and post-operative full blood counts from each patient participant.	24 months
Secondary	Patient blood transfusion requirements.	The number of units of packed red blood cells transfused for each patient participant (if applicable).	24 months
Secondary	Patient Hospital length of stay	Length of stay (total days) for each patient recruited into this study.	24 months
Secondary	Oxford Hip Score	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.	24 months
Secondary	EQ-5D	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.	24 months