Hip ReplacementPRIORITEESNCT06178185
A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty (PRIORITEES)
An observational study of Hip Replacement, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
Hip replacements are one of the NHS's highest volume procedures, with ~14,000 operations per month before the onset of the COVID-19 pandemic. Delays to surgery can have significant implications; meaning increasing levels of pain and worsening quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Replacement
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2023to 27 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients awaiting hip replacement surgery.
Who may be able to join
- Native hip arthritis
- On the waiting list for elective total hip replacement surgery
- Able to give informed consent to participate
- Existing medical records demonstrating 2 AP Pelvic Xray images taken at least 3 months apart
Who cannot join
- Inability to consent to participation
- Previous surgical intervention on the joint in question.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG
Julie Steen, 01691404210, julie.steen@nhs.net
About this study
Official title: Predicting Rapid Increases in Severity by Obligate Rotation & Improving Total Hip Expedited Elective Surgery (PRIORITEES); A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty
Hip replacements are one of the NHS's highest volume procedures, with ~14,000 operations per month before the onset of the COVID-19 pandemic. Delays to surgery can have significant implications; meaning increasing levels of pain and worsening quality of life.
As of January 2021, following the initial waves of the COVID-19 pandemic, 58,000 people had waited an average of 25 additional weeks for their total hip replacement.
The results of the study will hopefully help treating clinicians identify patients in whom there may be further deterioration if surgery is significantly delayed.
Read the detailed description
Patients attending their routine pre-operative assessment clinic who meet the inclusion criteria will be invited to take part in the study by their direct clinical care team. If they provide their consent, they will first be examined for their maximum hip internal rotation possible when supine with hip and knee flexed at 90 degrees.
They will then be asked to sit in front of a camera placed at a height 2 to 3 feet (0.6 to 0.9 m) off the ground and stand 6 feet (1.8 m) away(6). Patients will be asked to spread their feet as far apart from each other whilst sitting straight with hips and knees at 90 degrees. A photograph will be taken of their neutral position, and another with their best attempt at internal rotation.
The internal rotation angle obtained along with the photo number will be documented on a data collection sheet with a hospital sticker, BMI, oxford hip score and EQ5D score completed that day.
At the end of the day, this information shall be collated \& transcribed onto an excel spreadsheet for subsequent x-ray and photo review \& measurement, anonymisation and analysis.
- Conditions
- Hip Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this study is to evaluate the factors, including obligate external rotation, that are associated with risk of progression in hip OA.
The Deterioration Index (mm/week) will be calculated as the difference in average joint space width for the affected hip in AP X-Ray images taken at least 12 weeks apart, divided by the number of weeks between the X-Ray images assessed. The relationship with the parameters collated (age, BMI, KL grade, presence of OER) and DI will be evaluated to work out a cut-off value for high or low DI as part of the validation study.
The DI will also be evaluated as regards a relationship to the OHS and EQ5D to assess if there is a correlation with metrics used to assess subjective outcome in this patient cohort.
Measured: Participants attend clinic for a one-time clinic visit.
Secondary outcomes (2)
1-Develop a simple grading system based on the aforementioned results, to evaluate the feasibility of aiding clinicians in prioritising patients for THR.
The secondary aims of the study will be evaluated by analysing the suitability of a grading system for risk of progression of hip OA, based on factors that lead to the highest DI values.
The presence of OER will be evaluated and evidence of correlation to the photographic internal rotation angle, as well as quality of life scores will be assessed.
Measured: For approximately for 1 year, through study completion.
2-Validate the assessment of obligate external rotation remotely using a camera.
Participants will first be examined for their maximum hip internal rotation possible when supine with hip and knee flexed at 90 degrees.
They will then be asked to sit in front of a camera placed at a height 2 to 3 feet (0.6 to 0.9 m) off the ground and stand 6 feet (1.8 m) away(6). Patients will be asked to spread their feet as far apart from each other whilst sitting straight with hips and knees at 90 degrees. A photograph will be taken of their neutral position, and another with their best attempt at internal rotation.
The internal rotation angle obtained along with the photo number will be documented on a data collection sheet with a hospital sticker, BMI, oxford hip score and EQ5D score completed that day.
At the end of the day, this information shall be collated \& transcribed onto an excel spreadsheet for subsequent x-ray and photo review \& measurement, anonymisation and analysis.
Measured: For approximately for 1 year, through study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start27 Jun 2023
- Primary completion27 Jun 2024 (estimated)
- Study completion27 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip ReplacementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178185
- Sponsor's protocol ID
- RL1 868
- Acronym
- PRIORITEES
- Status last verified
- Dec 2023
- First submitted
- 29 Jun 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nikolova S, Harrison M, Sutton M. The Impact of Waiting Time on Health Gains from Surgery: Evidence from a National Patient-reported Outcome Dataset. Health Econ. 2016 Aug;25(8):955-68. doi: 10.1002/hec.3195. Epub 2015 May 26.
PubMed 26013773
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Rapid Increases in Severity by Obligate Rotation & Improving Total Hip Expedited Elective Surgery (PRIORITEES); A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06178185
- Acronym / sponsor ID
- PRIORITEES / RL1 868
- Conditions
- Hip Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 27 Jun 2024 (estimated)
- Study completion
- 27 Jun 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip replacements are one of the NHS's highest volume procedures, with ~14,000 operations per month before the onset of the COVID-19 pandemic. Delays to surgery can have significant implications; meaning increasing levels of pain and worsening quality of life.
As of January 2021, following the initial waves of the COVID-19 pandemic, 58,000 people had waited an average of 25 additional weeks for their total hip replacement.
The results of the study will hopefully help treating clinicians identify patients in whom there may be further deterioration if surgery is significantly delayed.
Detailed description
Patients attending their routine pre-operative assessment clinic who meet the inclusion criteria will be invited to take part in the study by their direct clinical care team. If they provide their consent, they will first be examined for their maximum hip internal rotation possible when supine with hip and knee flexed at 90 degrees.
They will then be asked to sit in front of a camera placed at a height 2 to 3 feet (0.6 to 0.9 m) off the ground and stand 6 feet (1.8 m) away(6). Patients will be asked to spread their feet as far apart from each other whilst sitting straight with hips and knees at 90 degrees. A photograph will be taken of their neutral position, and another with their best attempt at internal rotation.
The internal rotation angle obtained along with the photo number will be documented on a data collection sheet with a hospital sticker, BMI, oxford hip score and EQ5D score completed that day.
At the end of the day, this information shall be collated \& transcribed onto an excel spreadsheet for subsequent x-ray and photo review \& measurement, anonymisation and analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients awaiting hip replacement surgery.
Key inclusion criteria (4 listed)
- Native hip arthritis
- On the waiting list for elective total hip replacement surgery
- Able to give informed consent to participate
- Existing medical records demonstrating 2 AP Pelvic Xray images taken at least 3 months apart
Key exclusion criteria (2 listed)
- Inability to consent to participation
- Previous surgical intervention on the joint in question.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary aim of this study is to evaluate the factors, including obligate external rotation, that are associated with risk of progression in hip OA.
Time frame: Participants attend clinic for a one-time clinic visit.
The Deterioration Index (mm/week) will be calculated as the difference in average joint space width for the affected hip in AP X-Ray images taken at least 12 weeks apart, divided by the number of weeks between the X-Ray images assessed. The relationship with the parameters collated (age, BMI, KL grade, presence of OER) and DI will be evaluated to work out a cut-off value for high or low DI as part of the validation study. The DI will also be evaluated as regards a relationship to the OHS and EQ5D to assess if there is a correlation with metrics used to assess subjective outcome in this patient cohort.
2 secondary outcomes
1-Develop a simple grading system based on the aforementioned results, to evaluate the feasibility of aiding clinicians in prioritising patients for THR.
Time frame: For approximately for 1 year, through study completion.
2-Validate the assessment of obligate external rotation remotely using a camera.
Time frame: For approximately for 1 year, through study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Results publication: PubMed 26013773Nikolova S, Harrison M, Sutton M. The Impact of Waiting Time on Health Gains from Surgery: Evidence from a National Patient-reported Outcome Dataset. Health Econ. 2016 Aug;25(8):955-68. doi: 10.1002/hec.3195. Epub 2015 May 26.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Replacement, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust 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 4 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Steen (+441691404210, julie.steen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of this study is to evaluate the factors, including obligate external rotation, that are associated with risk of progression in hip OA. (time frame: Participants attend clinic for a one-time clinic visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178185, which also lists 1 linked publication.
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 20 Dec 2023.