A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty (PRIORITEES)

NCT06178185 | Unknown

• 1 other identifier: RL1 868
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Replacement

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  For approximately for 1 year, through study completion.

• 2-Validate the assessment of obligate external rotation remotely using a camera.

  For approximately for 1 year, through study completion.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients awaiting hip replacement surgery.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 26013773 RESULT

Central Study Contacts

Julie Steen

CONTACT

+441691404210; julie.steen@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: December 20, 2023
• Study Start: June 27, 2023
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

GB (1)