Hip Arthritis, Knee Arthritis
Conditions
Keywords
Hip Replacement, Knee Replacement
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.
Interventions
PROCEDUREHip/Knee Replacement
Hip/Knee Replacement
Sponsors
University of York
Northumbria Healthcare NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the inclusion criteria: 1. UK Resident 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
Exclusion criteria
Provided a participant meets all of the inclusion criteria, there are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EQ-5D-5L health-related quality of life score | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Hip Score | 2 years | — |
| Oxford Knee Score | 2 years | — |
| Musculoskeletal Health Questionnaire | 2 years | MSK-HQ |
| Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys | 2 years | Perception of success/fulfilment of expectations |
| Patient Health Questionnaire-4 | 2 years | PHQ-4 |
| 11-point Numerical Pain Rating Scale | 2 years | Pain |
| Pain Catastrophising Scale | 2 years | — |
| Length of stay | 2 years | Self-reported by study specific electronic questionnaire |
| PROMIS-10 | 2 years | Patient-Reported Outcomes Measurement Information System Global Health |
| Return to work | 2 years | Work status self-reported by electronic questionnaire using National Statistics Socio-economic Classification |
| 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 | — |
| Activity | 2 years | Levels of exercise and activity self-reported by study specific electronic questionnaire |
Countries
United Kingdom
Contacts
Primary ContactWilliam Fishley
Outcome results
None listed