Trial Outcomes & Findings for Total Hip Replacement Performance & Assessment (NCT NCT04267172)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

243 participants

Primary outcome timeframe

Intra-operatively (single patient participant)

Results posted on

2025-01-03

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.	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	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.	Surgical Residents With Additional Simulation Training - Patients Recruited Patients undergoing primary Total Hip Replacement by Surgical Residents With Additional Simulation Training.	Surgical Residents With Routine Training - Patients Recruited Patients undergoing primary Total Hip Replacement by Surgical Residents With Routine Surgical Training.	Orthopaedic Surgeon 'Experts & Fellows' - Patients Recruited Patients undergoing primary Total Hip Replacement by Arthroplasty Fellows or Consultants.
Overall Study STARTED	4	3	16	25	27	168
Overall Study COMPLETED	4	3	16	25	27	168
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Total Hip Replacement Performance & Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Residents With Additional Simulation Training n=4 Participants 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.	Surgical Residents With Routine Training n=3 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=16 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.	Surgical Residents With Additional Simulation Training - Patients", n=25 Participants Patients recruited into the study with operation led by surgical residents with additional simulation training (Group 1a)	"Surgical Residents With Routine Training - Patients", n=27 Participants Patients recruited into the study with operation led by surgical residents without additional simulation training (Group 1b)	"Orthopaedic Surgeon 'Experts & Fellows' - Patients" n=168 Participants Patients recruited into the study with operation led by Arthroplasty Fellows or Consultants.	Total n=243 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	51 Participants n=8 Participants	87 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	18 Participants n=4 Participants	21 Participants n=21 Participants	117 Participants n=8 Participants	156 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	21 Participants n=4 Participants	23 Participants n=21 Participants	109 Participants n=8 Participants	154 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	59 Participants n=8 Participants	89 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	23 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	25 Participants n=4 Participants	27 Participants n=21 Participants	168 Participants n=8 Participants	220 Participants n=8 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	3 participants n=7 Participants	16 participants n=5 Participants	25 participants n=4 Participants	27 participants n=21 Participants	168 participants n=8 Participants	243 participants n=8 Participants

PRIMARY outcome

Timeframe: Intra-operatively (single patient participant)

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

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 measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=4 Participants 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.	Surgical Residents With Routine Training n=3 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=16 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.
Surgeon Participant Intra-operative Motion Analysis	171,967 Movement counts Standard Deviation 41,867	172,258 Movement counts Standard Deviation 43,300	150,505 Movement counts Standard Deviation 38,190

PRIMARY outcome

Timeframe: 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.

Total time taken by each surgeon participant per step of the total hip replacement for each operation performed as lead surgeon.

Outcome measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=4 Participants 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.	Surgical Residents With Routine Training n=3 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=16 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.
Surgeon Participant Intra-operative Timings	4948 Seconds Standard Deviation 1119	4428 Seconds Standard Deviation 1122	3679 Seconds Standard Deviation 828

PRIMARY outcome

Timeframe: 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.

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 measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=4 Participants 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.	Surgical Residents With Routine Training n=3 Participants 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	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.
Surgical Trainee Global Rating Scale (GRS)	30 score on a scale Interval 23.0 to 33.0	31 score on a scale Interval 25.0 to 34.25	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=4 Participants 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.	Surgical Residents With Routine Training n=3 Participants 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	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.
Percent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating.	55.5 % of participants achieving level 4 OSAT	37.5 % of participants achieving level 4 OSAT	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=25 Participants 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.	Surgical Residents With Routine Training n=27 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=168 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.
Post-operative Patient X-ray	42.2 degrees Standard Deviation 6.7	43.0 degrees Standard Deviation 7.7	41.9 degrees Standard Deviation 7.8

SECONDARY outcome

Timeframe: 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.

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 measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=25 Participants 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.	Surgical Residents With Routine Training n=27 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=168 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.
Patient Blood Loss.	339 millilitres Standard Deviation 170	274 millilitres Standard Deviation 150	316 millilitres Standard Deviation 202

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=25 Participants 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.	Surgical Residents With Routine Training n=27 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=168 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.
Number of Participants Requiring a Blood Transfusion.	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=25 Participants 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.	Surgical Residents With Routine Training n=27 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=168 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.
Patient Hospital Length of Stay	2.95 days Standard Deviation 2.2	3.37 days Standard Deviation 2.59	2.41 days Standard Deviation 2.11

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Surgical Residents With Additional Simulation Training n=25 Participants 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.	Surgical Residents With Routine Training n=27 Participants 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	Orthopaedic Surgeon 'Experts & Fellows' n=168 Participants Consultant Orthopaedic Surgeons (n=8), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions.
Oxford Hip Score	26 Score on a scale. Standard Deviation 10	24 Score on a scale. Standard Deviation 8	25 Score on a scale. Standard Deviation 8

SECONDARY outcome

Timeframe: 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.

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).