Hip OsteoarthritisNCT04267172
Total Hip Replacement Performance & Assessment
A study testing Surgical simulation training in primary Total Hip Arthroplasty in people with Hip Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Surgical simulation training in primary Total Hip Arthroplasty
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with complex hip pathology (e.g. previous trauma, hip dysplasia, infection).
- Patients who have had previous surgery on their affected hip.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Botnar Research Centre
Oxford, Oxfordshire, OX3 7HE
About this study
Official title: A Prospective Randomised Controlled Study Assessing the Impact of Simulation Training in Primary Total Hip Replacement (THR).
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.
Read the 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:
- The Surgical Trainees who have undertaken additional simulation training versus those who have routine training.
- 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Surgical simulation training in primary Total Hip Arthroplasty, No intervention: Surgical Resident Control Group, No Intervention: Consultant and Fellow Comparator Group
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical simulation training in primary Total Hip ArthroplastyBehavioural
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.
No intervention: Surgical Resident Control GroupOther
Control Group
No Intervention: Consultant and Fellow Comparator GroupOther
Comparator Group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No Intervention: Consultant and Fellow Comparator Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.
Secondary outcomes (6)
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.
Measured: Assessment performed post-operatively within 8 weeks following procedure for each patient participant.
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.
Measured: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.
Number of Participants Requiring a Blood Transfusion.
The number of units of packed red blood cells transfused for each patient participant (if applicable).
Measured: Assessment performed per single patient participant during in-patient stay up to 14 days following operation.
Patient Hospital Length of Stay
Length of stay (total days) for each patient recruited into this study.
Measured: From post-operation through to hospital discharge.
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).
Measured: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively
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).
Measured: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start26 Feb 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Buckinghamshire Healthcare NHS Trust, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267172
- Sponsor's protocol ID
- 270167
- Status last verified
- Jan 2024
- First submitted
- 7 Nov 2019
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Study Assessing the Impact of Simulation Training in Primary Total Hip Replacement (THR).
- ClinicalTrials.gov ID
- NCT04267172
- Acronym / sponsor ID
- 270167
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Buckinghamshire Healthcare NHS Trust, Oxford University Hospitals NHS Trust
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The Surgical Trainees who have undertaken additional simulation training versus those who have routine training.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surgical Residents with additional simulation training | Experimental | Behavioral: Surgical simulation training in primary Total Hip ArthroplastySurgeon participant Group 1a: Interventional group ('StR's'): Trauma \& Orthopaedic Specialty Registrars (Surgical Residents) on Arthroplasty clinical placements (n=6-8) receiving additional simulation training. |
| Surgical Residents with routine training | Active comparator | Other: No intervention: Surgical Resident Control GroupSurgeon 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. |
| Orthopaedic Surgeon 'Experts & Fellows' | Active comparator | Other: No Intervention: Consultant and Fellow Comparator GroupConsultant Orthopaedic Surgeons (n=5), and nationally appointed Arthroplasty Fellows (n=8). Surgeon participants within this group will not undergo any interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with complex hip pathology (e.g. previous trauma, hip dysplasia, infection).
- Patients who have had previous surgery on their affected hip.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical simulation training in primary Total Hip ArthroplastyThe 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. | Behavioural | Surgical Residents with additional simulation training |
| No intervention: Surgical Resident Control GroupControl Group | Other | Surgical Residents with routine training |
| No Intervention: Consultant and Fellow Comparator GroupComparator Group | Other | Orthopaedic Surgeon 'Experts & Fellows' |
Primary outcome
Surgeon Participant Intra-operative Motion Analysis
Time frame: 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.
Surgeon Participant Intra-operative Timings
Time frame: 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.
Surgical Trainee Global Rating Scale (GRS)
Time frame: 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.
Time frame: 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.
6 secondary outcomes
Post-operative Patient X-ray
Time frame: Assessment performed post-operatively within 8 weeks following procedure for each patient participant.
Patient Blood Loss.
Time frame: Assessment performed post-operatively within 60 minutes following procedure for each patient participant.
Number of Participants Requiring a Blood Transfusion.
Time frame: Assessment performed per single patient participant during in-patient stay up to 14 days following operation.
Patient Hospital Length of Stay
Time frame: From post-operation through to hospital discharge.
Oxford Hip Score
Time frame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively
EQ-5D
Time frame: Determined for each recruited patient pre-operatively and again at 3-4 months post-operatively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical simulation training in primary Total Hip Arthroplasty in people with Hip Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Participant Intra-operative Motion Analysis (time frame: Intra-operatively (single patient participant)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.