QIST Collaborative - Arthroplasty Research Cohort (ARC) Study
NCT ID: NCT05824845
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2023-07-13
2031-05-31
Brief Summary
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1. To evaluate outcomes following hip and knee replacements.
2. To determine risk factors for adverse outcomes in primary hip and knee replacements.
3. To identify targets for future research and intervention in patients undergoing primary hip and knee replacements
4. 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ARC Study Cohort
Hip/Knee Replacement
Hip/Knee Replacement
Interventions
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Hip/Knee Replacement
Hip/Knee Replacement
Eligibility Criteria
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Inclusion Criteria
2. Able to read and understand documentation and questionnaires in English language
3. Undergoing elective primary hip or knee arthroplasty (THR, TKR or UKR)
4. Age 18 years or over
5. Provides the necessary consents relating to data collection and use of study data, data linkage, future research and invitation to involvement in future trials
18 Years
ALL
No
Sponsors
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University of York
OTHER
Northumbria Healthcare NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Northumbria Healthcare NHS Foundation Trust
Ashington, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ARC Study
Identifier Type: -
Identifier Source: org_study_id
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