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Clinical Trials/NCT05824845
NCT05824845
Recruiting
Not Applicable

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

Northumbria Healthcare NHS Foundation Trust1 site in 1 country5,000 target enrollmentJuly 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Arthritis
Sponsor
Northumbria Healthcare NHS Foundation Trust
Enrollment
5000
Locations
1
Primary Endpoint
EQ-5D-5L health-related quality of life score
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 13, 2023
End Date
May 2031
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.

Outcomes

Primary Outcomes

EQ-5D-5L health-related quality of life score

Time Frame: 2 years

Secondary Outcomes

  • PROMIS-10(2 years)
  • Oxford Hip Score(2 years)
  • Oxford Knee Score(2 years)
  • Pain Catastrophising Scale(2 years)
  • Activity(2 years)
  • Surgical Site Infection(2 years)
  • Patient Health Questionnaire-4(2 years)
  • Musculoskeletal Health Questionnaire(2 years)
  • Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys(2 years)
  • 11-point Numerical Pain Rating Scale(2 years)
  • Readmission within 30 days(30 days)
  • Dislocation(2 years)
  • Revision/Re-operation(2 years)
  • Length of stay(2 years)
  • Return to work(2 years)
  • Periprosthetic Fracture(2 years)
  • Mortality(2 years)

Study Sites (1)

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