A Prospective Randomised Controlled Study Assessing the Impact of Simulation Training in Primary Total Hip Replacement (THR).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Surgeon Participant Intra-operative Motion Analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Consultant assessors will be blinded to the grouping of the Surgical Residents (additional simulation training group, or control group).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with complex hip pathology (e.g. previous trauma, hip dysplasia, infection).
- •Patients who have had previous surgery on their affected hip.
结局指标
主要结局
Surgeon Participant Intra-operative Motion Analysis
时间窗: 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.
Surgeon Participant Intra-operative Timings
时间窗: 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.
Surgical Trainee Global Rating Scale (GRS)
时间窗: 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.
Percent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating.
时间窗: 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.
次要结局
- Post-operative Patient X-ray(Assessment performed post-operatively within 8 weeks following procedure for each patient participant.)
- Patient Blood Loss.(Assessment performed post-operatively within 60 minutes following procedure for each patient participant.)
- Number of Participants Requiring a Blood Transfusion.(Assessment performed per single patient participant during in-patient stay up to 14 days following operation.)
- Patient Hospital Length of Stay(From post-operation through to hospital discharge.)
- Oxford Hip Score(Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively)
- EQ-5D(Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively.)