QIST Collaborative - Arthroplasty Research Cohort (ARC) Study
- Conditions
- Hip ArthritisKnee Arthritis
- Registration Number
- NCT05824845
- Lead Sponsor
- Northumbria Healthcare NHS Foundation Trust
- Brief Summary
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:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
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
Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EQ-5D-5L health-related quality of life score 2 years
- Secondary Outcome Measures
Name Time Method PROMIS-10 2 years Patient-Reported Outcomes Measurement Information System Global Health
Oxford Hip Score 2 years Oxford Knee Score 2 years Pain Catastrophising Scale 2 years Activity 2 years Levels of exercise and activity self-reported by study specific electronic questionnaire
Surgical Site Infection 2 years Patient Health Questionnaire-4 2 years PHQ-4
Musculoskeletal Health Questionnaire 2 years MSK-HQ
Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys 2 years Perception of success/fulfilment of expectations
11-point Numerical Pain Rating Scale 2 years Pain
Readmission within 30 days 30 days Dislocation 2 years Revision/Re-operation 2 years Length of stay 2 years Self-reported by study specific electronic questionnaire
Return to work 2 years Work status self-reported by electronic questionnaire using National Statistics Socio-economic Classification
Periprosthetic Fracture 2 years Mortality 2 years
Trial Locations
- Locations (1)
Northumbria Healthcare NHS Foundation Trust
🇬🇧Ashington, United Kingdom
Northumbria Healthcare NHS Foundation Trust🇬🇧Ashington, United KingdomWilliam FishleyContact01912934087arcstudy@northumbria-healthcare.nhs.uk