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Recruiting NCT05824845

QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

— Observational Hip Arthritis Knee Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hip/Knee Replacement.
Who it may be relevant to
Registry conditions: Hip Arthritis, Knee Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Procedure Hip/Knee Replacement
    Hip/Knee Replacement

Primary outcome measures

  • EQ-5D-5L health-related quality of life score [Time frame: 2 years]
Secondary outcome measures (12)
  • PROMIS-10 [Time frame: 2 years]
  • Oxford Hip Score [Time frame: 2 years]
  • Oxford Knee Score [Time frame: 2 years]
  • Musculoskeletal Health Questionnaire [Time frame: 2 years]
  • Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys [Time frame: 2 years]
  • Patient Health Questionnaire-4 [Time frame: 2 years]
  • 11-point Numerical Pain Rating Scale [Time frame: 2 years]
  • Pain Catastrophising Scale [Time frame: 2 years]
  • Length of stay [Time frame: 2 years]
  • Activity [Time frame: 2 years]
  • Return to work [Time frame: 2 years]
  • Readmission within 30 days [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Northumbria Healthcare NHS Foundation Trust — Ashington

Identifiers

NCT: NCT05824845 · ARC Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗