Total Hip Replacement Performance & Assessment

NCT04267172 | Completed Results DMC

• 1 other identifier: 270167
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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.

Secondary Outcomes (6)

• 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

Study Arms (3)

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.

Behavioral: Surgical simulation training in primary Total Hip Arthroplasty

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.

Other: No intervention: Surgical Resident Control Group

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.

Other: No Intervention: Consultant and Fellow Comparator Group

Interventions

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.

Surgical Residents with additional simulation training

No intervention: Surgical Resident Control Group OTHER

Control Group

Surgical Residents with routine training

No Intervention: Consultant and Fellow Comparator Group OTHER

Comparator Group

Orthopaedic Surgeon 'Experts & Fellows'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with complex hip pathology (e.g. previous trauma, hip dysplasia, infection).
• Patients who have had previous surgery on their affected hip.

Sponsors & Collaborators

• University of Oxford: lead
• Buckinghamshire Healthcare NHS Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Botnar Research Centre

Oxford, Oxfordshire, OX3 7HE, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Professor Jonathan Rees
• Organization: Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford.

jonathan.rees@ndorms.ox.ac.uk

01865737540

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Consultant assessors will be blinded to the grouping of the Surgical Residents (additional simulation training group, or control group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: February 12, 2020
• Study Start: February 26, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-01

Locations

GB (1)