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| Name | Class |
|---|---|
| Buckinghamshire Healthcare NHS Trust | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Residents with additional simulation training | Experimental | Surgeon participant Group 1a: Interventional group ('StR's'): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=6-8) receiving additional simulation training. |
|
| Surgical Residents with routine training | Active Comparator | Surgeon participant Group 1b: control group (StR's): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=6-8) receiving routine and normal training. |
|
| Orthopaedic Surgeon 'Experts & Fellows' | Active Comparator | Consultant Orthopaedic Surgeons (n=5), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Participant Intra-operative Motion Analysis | 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. | Intra-operatively (single patient participant) |
| Surgeon Participant Intra-operative Timings | Total time taken by each surgeon participant per step of the total hip replacement for each operation performed as lead surgeon. | Intra-operatively (single patient participant) |
| 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. GRS only performed for group 1a and 1b (i.e. Residents). Expert group did not have GRS collected. | Assessment performed post-operatively within 60 minutes following procedure for each patient participant. |
| Percent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating. | 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. | Assessment performed post-operatively within 60 minutes following procedure for each patient participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Patient X-ray | 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. | Assessment performed post-operatively within 8 weeks following procedure for each patient participant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botnar Research Centre | Oxford | Oxfordshire | OX3 7HE | United Kingdom |
The number of patients recruited exceeded the number in protocol enrolment as it was necessary to continue patient recruitment within the Resident Groups to achieve the required number to power the primary outcome (i.e. operative time, n=25 in group 1a and 1b).
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Residents With Additional Simulation Training | Surgeon participant Group 1a: Interventional group ('StR's'): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=4) receiving additional simulation training. 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. |
| FG001 | Surgical Residents With Routine Training | Surgeon participant Group 1b: control group (StR's): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=3) receiving routine and normal training. No intervention: Surgical Resident Control Group: Control Group |
| FG002 | Orthopaedic Surgeon 'Experts & Fellows' | Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions. |
| FG003 | Surgical Residents With Additional Simulation Training - Patients | Recruited Patients undergoing primary Total Hip Replacement by Surgical Residents With Additional Simulation Training. |
| FG004 | Surgical Residents With Routine Training - Patients | Recruited Patients undergoing primary Total Hip Replacement by Surgical Residents With Routine Surgical Training. |
| FG005 | Orthopaedic Surgeon 'Experts & Fellows' - Patients | Recruited Patients undergoing primary Total Hip Replacement by Arthroplasty Fellows or Consultants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Residents With Additional Simulation Training | Surgeon participant Group 1a: Interventional group ('StR's'): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=4) receiving additional simulation training. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Surgeon Participant Intra-operative Motion Analysis | 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. | Outcome measure results represent the group mean average and standard deviations. Only Surgeon participants were assessed. | Posted | Mean | Standard Deviation | Movement counts | Intra-operatively (single patient participant) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Residents With Additional Simulation Training | Surgeon participant Group 1a: Interventional group ('StR's'): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=4) receiving additional simulation training. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Jonathan Rees | Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford. | 01865737540 | jonathan.rees@ndorms.ox.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2019 | Jan 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Consent | Oct 12, 2019 | Jan 12, 2024 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Surgeon Consent: Residents | Oct 12, 2019 | Jan 12, 2024 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Surgeon Consent: Fellows and Consultants | Oct 12, 2019 | Jan 12, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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Consultant assessors will be blinded to the grouping of the Surgical Residents (additional simulation training group, or control group).
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| No intervention: Surgical Resident Control Group | Other | Control Group |
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| No Intervention: Consultant and Fellow Comparator Group | Other | Comparator Group |
|
| Patient Blood Loss. |
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. |
| Assessment performed post-operatively within 60 minutes following procedure for each patient participant. |
| Number of Participants Requiring a Blood Transfusion. | The number of units of packed red blood cells transfused for each patient participant (if applicable). | Assessment performed per single patient participant during in-patient stay up to 14 days following operation. |
| Patient Hospital Length of Stay | Length of stay (total days) for each patient recruited into this study. | From post-operation through to hospital discharge. |
| 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. 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). | Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively |
| 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. 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). | Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively. |
| BG001 | Surgical Residents With Routine Training | Surgeon participant Group 1b: control group (StR's): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=3) receiving routine and normal training. No intervention: Surgical Resident Control Group: Control Group |
| BG002 | Orthopaedic Surgeon 'Experts & Fellows' | Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions. |
| BG003 | Surgical Residents With Additional Simulation Training - Patients", | Patients recruited into the study with operation led by surgical residents with additional simulation training (Group 1a) |
| BG004 | "Surgical Residents With Routine Training - Patients", | Patients recruited into the study with operation led by surgical residents without additional simulation training (Group 1b) |
| BG005 | "Orthopaedic Surgeon 'Experts & Fellows' - Patients" | Patients recruited into the study with operation led by Arthroplasty Fellows or Consultants. |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Surgical Residents With Routine Training | Surgeon participant Group 1b: control group (StR's): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=3) receiving routine and normal training. No intervention: Surgical Resident Control Group: Control Group |
| OG002 | Orthopaedic Surgeon 'Experts & Fellows' | Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions. |
|
|
| Primary | Surgeon Participant Intra-operative Timings | Total time taken by each surgeon participant per step of the total hip replacement for each operation performed as lead surgeon. | Outcome measure results represent the group mean average and standard deviations for total operative time. Only Surgeon participants were assessed. | Posted | Mean | Standard Deviation | Seconds | Intra-operatively (single patient participant) |
|
|
|
| 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. GRS only performed for group 1a and 1b (i.e. Residents). Expert group did not have GRS collected. | Outcome measure results represent the group median average and interquartile ranges. Only Surgical Resident participants were assessed. | Posted | Median | Inter-Quartile Range | score on a scale | Assessment performed post-operatively within 60 minutes following procedure for each patient participant. |
|
|
|
| Primary | Percent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating. | 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. | The OSAT used was a standardised, validated OSAT used by the joint committee of surgical training (JCST) in the UK. Only Surgical Resident participants were assessed. | Posted | Number | % of participants achieving level 4 OSAT | Assessment performed post-operatively within 60 minutes following procedure for each patient participant. |
|
|
|
| Secondary | Post-operative Patient X-ray | 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. | radiographic inclination of acetabular cup. Outcome measure results represent the group mean average and standard deviation. Only patient participants were assessed. | Posted | Mean | Standard Deviation | degrees | Assessment performed post-operatively within 8 weeks following procedure for each patient participant. |
|
|
|
| Secondary | Patient Blood Loss. | 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. | Outcome measure results represent the group mean average and standard deviations. Only patient participants were assessed. | Posted | Mean | Standard Deviation | millilitres | Assessment performed post-operatively within 60 minutes following procedure for each patient participant. |
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|
|
| Secondary | Number of Participants Requiring a Blood Transfusion. | The number of units of packed red blood cells transfused for each patient participant (if applicable). | Blood transfusions required. Only patient participants were assessed. | Posted | Count of Participants | Participants | No | Assessment performed per single patient participant during in-patient stay up to 14 days following operation. |
|
|
|
| Secondary | Patient Hospital Length of Stay | Length of stay (total days) for each patient recruited into this study. | Length of post-operative in-patient stay (days). Outcome measure results represent the group mean average and standard deviation. Only patient participants were assessed. | Posted | Mean | Standard Deviation | days | From post-operation through to hospital discharge. |
|
|
|
| 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. 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). | Change in OHS. Outcome measure results represent the group mean average and standard deviation. Only patient participants were assessed. | Posted | Mean | Standard Deviation | Score on a scale. | Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively |
|
|
|
| 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. 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). | Change in EQ-5D VAS. Outcome measure results represent the group mean average and standard deviation. Only patient participants were assessed. | Posted | Mean | Standard Deviation | Score on a scale. | Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively. |
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|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Surgical Residents With Routine Training | Surgeon participant Group 1b: control group (StR's): Trauma & Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=3) receiving routine and normal training. No intervention: Surgical Resident Control Group: Control Group | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Orthopaedic Surgeon 'Experts & Fellows' | Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Surgical Residents With Additional Simulation Training - Patients. | Recruited Patients undergoing primary Total Hip Replacement by Surgical Residents with Additional Simulation Training. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG004 | Surgical Residents With Routine Training - Patients. | Recruited Patients undergoing primary Total Hip Replacement by Surgical Residents with Routine Surgical Training. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG005 | Orthopaedic Surgeon 'Experts & Fellows' - Patients. | Recruited Patients undergoing primary Total Hip Replacement by Arthroplasty Fellows or Consultants. | 0 | 168 | 0 | 168 | 0 | 168 |
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| D012216 |
| Rheumatic Diseases |