Predicting Rapid Increases in Severity by Obligate Rotation & Improving Total Hip Expedited Elective Surgery (PRIORITEES); A Novel Study Evaluating Patients Awaiting Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Inability to consent to participation
- •Previous surgical intervention on the joint in question.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)