Clinical trial NCT05824845: QIST Collaborative - Arthroplasty Research Cohort (ARC) Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthritis
Knee Arthritis
Keywords: Hip Replacement
Knee Replacement
Lead sponsor: Northumbria Healthcare NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of York
First posted: 2023-04-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UK Residents age 18 years or over undergoing elective primary hip or 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.


Eligibility criteria: 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 exclusion criteria for the cohort study.

Primary outcomes:
measure: EQ-5D-5L health-related quality of life score
timeFrame: 2 years
Secondary outcomes:
measure: PROMIS-10
timeFrame: 2 years
measure: Oxford Hip Score
timeFrame: 2 years
measure: Oxford Knee Score
timeFrame: 2 years
measure: Musculoskeletal Health Questionnaire
timeFrame: 2 years
measure: Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys
timeFrame: 2 years
measure: Patient Health Questionnaire-4
timeFrame: 2 years
measure: 11-point Numerical Pain Rating Scale
timeFrame: 2 years
measure: Pain Catastrophising Scale
timeFrame: 2 years
measure: Length of stay
timeFrame: 2 years
measure: Activity
timeFrame: 2 years
measure: Return to work
timeFrame: 2 years
measure: Readmission within 30 days
timeFrame: 30 days
measure: Surgical Site Infection
timeFrame: 2 years
measure: Periprosthetic Fracture
timeFrame: 2 years
measure: Dislocation
timeFrame: 2 years
measure: Revision/Re-operation
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Ashington
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
Study officials:
References: