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Total Hip Replacement Performance & Assessment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04267172
Enrollment
243
Registered
2020-02-12
Start date
2020-02-26
Completion date
2022-02-28
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis

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.

Interventions

BEHAVIORALSurgical 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.

OTHERNo intervention: Surgical Resident Control Group

Control Group

OTHERNo Intervention: Consultant and Fellow Comparator Group

Comparator Group

Sponsors

Buckinghamshire Healthcare NHS Trust
CollaboratorOTHER
Oxford University Hospitals NHS Trust
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Consultant assessors will be blinded to the grouping of the Surgical Residents (additional simulation training group, or control group).

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Surgeon Participant Intra-operative Motion AnalysisIntra-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 TimingsIntra-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)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.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.

Secondary

MeasureTime frameDescription
Oxford Hip ScoreDetermined for each recruited patient pre-operatively and again at 3-4 months post-operativelyA 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).
Post-operative Patient X-rayAssessment performed post-operatively within 8 weeks following procedure for each patient participant.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.
EQ-5DDetermined for each recruited patient pre-operatively and again at 3-4 months post-operatively.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).
Patient Blood Loss.Assessment performed post-operatively within 60 minutes following procedure for each patient participant.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.
Number of Participants Requiring a Blood Transfusion.Assessment performed per single patient participant during in-patient stay up to 14 days following operation.The number of units of packed red blood cells transfused for each patient participant (if applicable).
Patient Hospital Length of StayFrom post-operation through to hospital discharge.Length of stay (total days) for each patient recruited into this study.

Countries

United Kingdom

Participant flow

Pre-assignment details

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).

Participants by arm

ArmCount
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.
4
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
3
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.
16
Surgical Residents With Additional Simulation Training - Patients,
Patients recruited into the study with operation led by surgical residents with additional simulation training (Group 1a)
25
Surgical Residents With Routine Training - Patients,
Patients recruited into the study with operation led by surgical residents without additional simulation training (Group 1b)
27
Orthopaedic Surgeon 'Experts & Fellows' - Patients
Patients recruited into the study with operation led by Arthroplasty Fellows or Consultants.
168
Total243

Baseline characteristics

CharacteristicSurgical Residents With Additional Simulation TrainingSurgical Residents With Routine TrainingOrthopaedic Surgeon 'Experts & Fellows'Surgical Residents With Additional Simulation Training - Patients,Surgical Residents With Routine Training - Patients,Orthopaedic Surgeon 'Experts & Fellows' - PatientsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants18 Participants21 Participants117 Participants156 Participants
Age, Categorical
Between 18 and 65 years
4 Participants3 Participants16 Participants7 Participants6 Participants51 Participants87 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants3 Participants16 Participants0 Participants0 Participants0 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants25 Participants27 Participants168 Participants220 Participants
Region of Enrollment
United Kingdom
4 participants3 participants16 participants25 participants27 participants168 participants243 participants
Sex: Female, Male
Female
1 Participants0 Participants0 Participants21 Participants23 Participants109 Participants154 Participants
Sex: Female, Male
Male
3 Participants3 Participants16 Participants4 Participants4 Participants59 Participants89 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 30 / 160 / 250 / 270 / 168
other
Total, other adverse events
0 / 40 / 30 / 160 / 250 / 270 / 168
serious
Total, serious adverse events
0 / 40 / 30 / 160 / 250 / 270 / 168

Outcome results

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.

Time frame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.

Population: 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.

ArmMeasureValue (NUMBER)
Surgical Residents With Additional Simulation TrainingPercent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating.55.5 % of participants achieving level 4 OSAT
Surgical Residents With Routine TrainingPercent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating.37.5 % of participants achieving level 4 OSAT
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.

Time frame: Intra-operatively (single patient participant)

Population: Outcome measure results represent the group mean average and standard deviations.~Only Surgeon participants were assessed.

ArmMeasureValue (MEAN)
Surgical Residents With Additional Simulation TrainingSurgeon Participant Intra-operative Motion Analysis171,967 Movement counts
Surgical Residents With Routine TrainingSurgeon Participant Intra-operative Motion Analysis172,258 Movement counts
Orthopaedic Surgeon 'Experts & Fellows'Surgeon Participant Intra-operative Motion Analysis150,505 Movement counts
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.

Time frame: Intra-operatively (single patient participant)

Population: Outcome measure results represent the group mean average and standard deviations for total operative time.~Only Surgeon participants were assessed.

ArmMeasureValue (MEAN)Dispersion
Surgical Residents With Additional Simulation TrainingSurgeon Participant Intra-operative Timings4948 SecondsStandard Deviation 1119
Surgical Residents With Routine TrainingSurgeon Participant Intra-operative Timings4428 SecondsStandard Deviation 1122
Orthopaedic Surgeon 'Experts & Fellows'Surgeon Participant Intra-operative Timings3679 SecondsStandard Deviation 828
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.

Time frame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.

Population: Outcome measure results represent the group median average and interquartile ranges.~Only Surgical Resident participants were assessed.

ArmMeasureValue (MEDIAN)
Surgical Residents With Additional Simulation TrainingSurgical Trainee Global Rating Scale (GRS)30 score on a scale
Surgical Residents With Routine TrainingSurgical Trainee Global Rating Scale (GRS)31 score on a scale
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).

Time frame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively.

Population: Change in EQ-5D VAS. Outcome measure results represent the group mean average and standard deviation.~Only patient participants were assessed.

ArmMeasureValue (MEAN)Dispersion
Surgical Residents With Additional Simulation TrainingEQ-5D19 Score on a scale.Standard Deviation 14
Surgical Residents With Routine TrainingEQ-5D19 Score on a scale.Standard Deviation 16
Orthopaedic Surgeon 'Experts & Fellows'EQ-5D19 Score on a scale.Standard Deviation 14
Secondary

Number of Participants Requiring a Blood Transfusion.

The number of units of packed red blood cells transfused for each patient participant (if applicable).

Time frame: Assessment performed per single patient participant during in-patient stay up to 14 days following operation.

Population: Blood transfusions required. Only patient participants were assessed.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Surgical Residents With Additional Simulation TrainingNumber of Participants Requiring a Blood Transfusion.0 Participants
Surgical Residents With Routine TrainingNumber of Participants Requiring a Blood Transfusion.1 Participants
Orthopaedic Surgeon 'Experts & Fellows'Number of Participants Requiring a Blood Transfusion.1 Participants
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).

Time frame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively

Population: Change in OHS. Outcome measure results represent the group mean average and standard deviation.~Only patient participants were assessed.

ArmMeasureValue (MEAN)Dispersion
Surgical Residents With Additional Simulation TrainingOxford Hip Score26 Score on a scale.Standard Deviation 10
Surgical Residents With Routine TrainingOxford Hip Score24 Score on a scale.Standard Deviation 8
Orthopaedic Surgeon 'Experts & Fellows'Oxford Hip Score25 Score on a scale.Standard Deviation 8
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.

Time frame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.

Population: Outcome measure results represent the group mean average and standard deviations.~Only patient participants were assessed.

ArmMeasureValue (MEAN)Dispersion
Surgical Residents With Additional Simulation TrainingPatient Blood Loss.339 millilitresStandard Deviation 170
Surgical Residents With Routine TrainingPatient Blood Loss.274 millilitresStandard Deviation 150
Orthopaedic Surgeon 'Experts & Fellows'Patient Blood Loss.316 millilitresStandard Deviation 202
Secondary

Patient Hospital Length of Stay

Length of stay (total days) for each patient recruited into this study.

Time frame: From post-operation through to hospital discharge.

Population: Length of post-operative in-patient stay (days). Outcome measure results represent the group mean average and standard deviation.~Only patient participants were assessed.

ArmMeasureValue (MEAN)Dispersion
Surgical Residents With Additional Simulation TrainingPatient Hospital Length of Stay2.95 daysStandard Deviation 2.2
Surgical Residents With Routine TrainingPatient Hospital Length of Stay3.37 daysStandard Deviation 2.59
Orthopaedic Surgeon 'Experts & Fellows'Patient Hospital Length of Stay2.41 daysStandard Deviation 2.11
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.

Time frame: Assessment performed post-operatively within 8 weeks following procedure for each patient participant.

Population: radiographic inclination of acetabular cup. Outcome measure results represent the group mean average and standard deviation.~Only patient participants were assessed.

ArmMeasureValue (MEAN)Dispersion
Surgical Residents With Additional Simulation TrainingPost-operative Patient X-ray42.2 degreesStandard Deviation 6.7
Surgical Residents With Routine TrainingPost-operative Patient X-ray43.0 degreesStandard Deviation 7.7
Orthopaedic Surgeon 'Experts & Fellows'Post-operative Patient X-ray41.9 degreesStandard Deviation 7.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026