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| Name | Class |
|---|---|
| University of York | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARC Study Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip/Knee Replacement | Procedure | Hip/Knee Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-5L health-related quality of life score | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-10 | Patient-Reported Outcomes Measurement Information System Global Health | 2 years |
| Oxford Hip Score | 2 years | |
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Inclusion Criteria:
Participants must meet all of the inclusion criteria:
Exclusion Criteria:
Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.
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UK Residents age 18 years or over undergoing elective primary hip or knee replacement
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Fishley | Contact | 01912934087 | arcstudy@northumbria-healthcare.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria Healthcare NHS Foundation Trust | Recruiting | Ashington | United Kingdom |
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| 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 |