QIST Collaborative - Arthroplasty Research Cohort (ARC) Study - a Collaborative, Longitudinal Observational Cohort Study of Patients Undergoing Primary Hip and Knee Replacements in the United Kingdom
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- EQ-5D-5L health-related quality of life score
研究概览
简要总结
The ARC Study is a national observational cohort study to investigate patient reported and clinical outcomes after hip and knee replacements. The study has the following objectives:
- To evaluate outcomes following hip and knee replacements.
- To determine risk factors for adverse outcomes in primary hip and knee replacements.
- To identify targets for future research and intervention in patients undergoing primary hip and knee replacements
- To provide a resource from which to identify potential participants for future clinical trials, and to use data collected in the ARC Study as comparison or control data for trial participants who have been randomised to receive one or more interventions.
Participants are recruited and consented online. Patients are invited to participate by collaborating surgical teams nationally in outpatient clinics at the time of being added to a waiting list, in addition to an advertising campaign to recruit patients. They are directed to an online portal where they will be able to review further information.
Consent and data collection is completed electronically through patients entering data online. Baseline demographics and characteristics are recorded, including details of socio-demographics, lifestyle, health status and patient reported outcome measures (PROMs). Patients then undergo hip/knee replacement and postoperative rehabilitation according to the standard care and protocols of the hospital and the preferences of their treating surgeon.
Follow-up data, including PROMs, is collected via online questionnaires up to two years following surgery. The study will ultimately also enable multiple trials to be embedded within the cohort study, using a 'Trials within Cohorts' (TwiCs) methodology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the inclusion criteria:
- •UK Resident
- •Able to read and understand documentation and questionnaires in English language
- •Undergoing elective primary hip or knee arthroplasty (THR, TKR or UKR)
- •Age 18 years or over
- •Provides the necessary consents relating to data collection and use of study data, data linkage, future research and invitation to involvement in future trials
排除标准
- •Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.
结局指标
主要结局
EQ-5D-5L health-related quality of life score
时间窗: 2 years
次要结局
- PROMIS-10(2 years)
- Oxford Hip Score(2 years)
- Oxford Knee Score(2 years)
- Pain Catastrophising Scale(2 years)
- Activity(2 years)
- Surgical Site Infection(2 years)
- Patient Health Questionnaire-4(2 years)
- Musculoskeletal Health Questionnaire(2 years)
- Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys(2 years)
- 11-point Numerical Pain Rating Scale(2 years)
- Readmission within 30 days(30 days)
- Dislocation(2 years)
- Revision/Re-operation(2 years)
- Length of stay(2 years)
- Return to work(2 years)
- Periprosthetic Fracture(2 years)
- Mortality(2 years)