QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hip Arthritis, Knee Arthritis

Intervention / Treatment
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* Procedure: Hip/Knee Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ARC Study Cohort<br> | Procedure: Hip/Knee Replacement<br>* Hip/Knee Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L health-related quality of life score |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS-10 | Patient-Reported Outcomes Measurement Information System Global Health | 2 years | 
| Oxford Hip Score |  | 2 years | 
| Oxford Knee Score |  | 2 years | 
| Musculoskeletal Health Questionnaire | MSK-HQ | 2 years | 
| Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys | Perception of success/fulfilment of expectations | 2 years | 
| Patient Health Questionnaire-4 | PHQ-4 | 2 years | 
| 11-point Numerical Pain Rating Scale | Pain | 2 years | 
| Pain Catastrophising Scale |  | 2 years | 
| Length of stay | Self-reported by study specific electronic questionnaire | 2 years | 
| Activity | Levels of exercise and activity self-reported by study specific electronic questionnaire | 2 years | 
| Return to work | Work status self-reported by electronic questionnaire using National Statistics Socio-economic Classification | 2 years | 
| Readmission within 30 days |  | 30 days | 
| Surgical Site Infection |  | 2 years | 
| Periprosthetic Fracture |  | 2 years | 
| Dislocation |  | 2 years | 
| Revision/Re-operation |  | 2 years | 
| Mortality |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Replacement, Knee Replacement