Clinical trial NCT06178185: A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty (PRIORITEES)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Replacement
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
First posted: 2023-12-20
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients awaiting hip replacement surgery.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Inability to consent to participation
* Previous surgical intervention on the joint in question.

Primary outcomes:
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.
timeFrame: Participants attend clinic for a one-time clinic visit.
Secondary outcomes:
measure: 1-Develop a simple grading system based on the aforementioned results, to evaluate the feasibility of aiding clinicians in prioritising patients for THR.
timeFrame: For approximately for 1 year, through study completion.
measure: 2-Validate the assessment of obligate external rotation remotely using a camera.
timeFrame: For approximately for 1 year, through study completion.
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
state: Shropshire
Study officials:
References:
citation: 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.