Total Hip Replacement Performance & Assessment

Sponsor
University of Oxford (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04267172
Collaborator
Buckinghamshire Healthcare NHS Trust (Other), Oxford University Hospitals NHS Trust (Other)
23
Enrollment
1
Location
3
Arms
36.1
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Surgical simulation training in primary Total Hip Arthroplasty
  • Other: No intervention: Surgical Resident Control Group
  • Other: No Intervention: Consultant and Fellow Comparator Group
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
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).
Primary Purpose:
Treatment
Official Title:
A Prospective Randomised Controlled Study Assessing the Impact of Simulation Training in Primary Total Hip Replacement (THR).
Actual Study Start Date :
Feb 26, 2020
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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=6-8) receiving additional simulation training.

Behavioral: Surgical 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.

Active Comparator: Surgical Residents with routine training

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
Control Group

Active Comparator: Orthopaedic Surgeon 'Experts & Fellows'

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
Comparator Group

Outcome Measures

Primary Outcome Measures

  1. Surgeon participant intra-operative motion analysis [24 months]

    Total number of surgeon hand movements obtained from elbow worn wireless motion sensors.

  2. Surgeon participant intra-operative timings [24 months]

    Total time taken by each surgeon participant per step of the total hip replacement.

  3. Surgical Trainee Global Rating Scale (GRS) [24 months]

    A subjective human grading assessment of surgical performance rated on a scale of 7-35 with a higher score indicating a better surgical performance.

  4. Objective Structured Assessment of Technical Skills (OSATS) [24 months]

    A subjective human grading assessment of surgical performance. Rated on a 5 point scale, with a higher score indicating a more competently performed procedure.

Secondary Outcome Measures

  1. Post-operative patient X-ray [24 months]

    Post-operative X-ray analysis for component positioning, orientation, and quality of cementing for each patient recruited into this study.

  2. Patient blood loss. [24 months]

    Pre- and post-operative full blood counts from each patient participant.

  3. Patient blood transfusion requirements. [24 months]

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

  4. Patient Hospital length of stay [24 months]

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

  5. Oxford Hip Score [24 months]

    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.

  6. EQ-5D [24 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Botnar Research CentreOxfordOxfordshireUnited KingdomOX3 7HE

Sponsors and Collaborators

  • University of Oxford
  • Buckinghamshire Healthcare NHS Trust
  • Oxford University Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT04267172
Other Study ID Numbers:
  • 270167
First Posted:
Feb 12, 2020
Last Update Posted:
Feb 25, 2022
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022