Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178185
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-06-29
Brief Title:
A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty PRIORITEES
Sponsor:
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Organization:
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIORITEES
Brief Summary:
Hip replacements are one of the NHSs highest volume procedures with 14000 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 58000 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
As of January 2021 following the initial waves of the COVID-19 pandemic 58000 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 06 to 09 m off the ground and stand 6 feet 18 m away6 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
They will then be asked to sit in front of a camera placed at a height 2 to 3 feet 06 to 09 m off the ground and stand 6 feet 18 m away6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None