NCT04267172

Total Hip Replacement Performance & Assessment

Completed NA Results posted Last updated 3 January 2025

What this trial tests

NA trial testing Surgical simulation training in primary Total Hip Arthroplasty in Hip Osteoarthritis in 243 participants. Completed in 28 February 2022.

Timeline

26 February 2020

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	University of Oxford
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	243
Start date	26 February 2020
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Surgical simulation training in primary Total Hip Arthroplasty
• No intervention: Surgical Resident Control Group
• No Intervention: Consultant and Fellow Comparator Group

Conditions studied

• Hip Osteoarthritis — all drugs for Hip Osteoarthritis →

Sponsor

University of Oxford

Who can join

18 and older, any sex, with Hip Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Surgeon Participant Intra-operative Motion Analysis Primary · 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.

Group	Value	95% CI
Surgical Residents With Additional Simulation Training	171,967	± 41,867
Surgical Residents With Routine Training	172,258	± 43,300
Orthopaedic Surgeon 'Experts & Fellows'	150,505	± 38,190

Surgeon Participant Intra-operative Timings Primary · 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.

Group	Value	95% CI
Surgical Residents With Additional Simulation Training	4948	± 1119
Surgical Residents With Routine Training	4428	± 1122
Orthopaedic Surgeon 'Experts & Fellows'	3679	± 828

Surgical Trainee Global Rating Scale (GRS) Primary · 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.

Group	Value	95% CI
Surgical Residents With Additional Simulation Training	30	23 – 33
Surgical Residents With Routine Training	31	25 – 34.25

Percent of Participants With 4+ Objective Structured Assessment of Technical Skills (OSATS) Rating. Primary · 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.

Group	Value	95% CI
Surgical Residents With Additional Simulation Training	55.5
Surgical Residents With Routine Training	37.5

Post-operative Patient X-ray Secondary · Assessment 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.

Group	Value	95% CI
Surgical Residents With Additional Simulation Training - Patients.	42.2	± 6.7
Surgical Residents With Routine Training - Patients.	43.0	± 7.7
Orthopaedic Surgeon 'Experts & Fellows' - Patients.	41.9	± 7.8

Patient Blood Loss. Secondary · 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.

Group	Value	95% CI
Surgical Residents With Additional Simulation Training - Patients.	339	± 170
Surgical Residents With Routine Training - Patients.	274	± 150
Orthopaedic Surgeon 'Experts & Fellows' - Patients.	316	± 202

Number of Participants Requiring a Blood Transfusion. Secondary · 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).

Group	Value	95% CI
Surgical Residents With Additional Simulation Training - Patients.	0
Surgical Residents With Routine Training - Patients.	1
Orthopaedic Surgeon 'Experts & Fellows' - Patients.	1

Patient Hospital Length of Stay Secondary · From post-operation through to hospital discharge.

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

Group	Value	95% CI
Surgical Residents With Additional Simulation Training - Patients.	2.95	± 2.2
Surgical Residents With Routine Training - Patients.	3.37	± 2.59
Orthopaedic Surgeon 'Experts & Fellows' - Patients.	2.41	± 2.11

Oxford Hip Score Secondary · Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively

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).

Group	Value	95% CI
Surgical Residents With Additional Simulation Training - Patients.	26	± 10
Surgical Residents With Routine Training - Patients.	24	± 8
Orthopaedic Surgeon 'Experts & Fellows' - Patients.	25	± 8

EQ-5D Secondary · Determined 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).

Group	Value	95% CI
Surgical Residents With Additional Simulation Training - Patients.	19	± 14
Surgical Residents With Routine Training - Patients.	19	± 16
Orthopaedic Surgeon 'Experts & Fellows' - Patients.	19	± 14

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Key performance and training parameters in primary total hip arthroplasty - an expert consensus using the Delphi technique.
   Howgate D, Garfjeld Roberts P, Kendrick B, Rees J. · · 2023 · cited 4× · PMID 34748447 · DOI 10.1177/11207000211056864