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NCT Number: NCT05824845

QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northumbria Healthcare NHS Foundation Trust

Ashington, United Kingdom

Location status: Recruiting

Location contact

William Fishley

CONTACT

[email protected]

01912934087

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hip/Knee Replacement

Procedure

Hip/Knee Replacement

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. PROMIS-10

    Time frame: 2 years

    Patient-Reported Outcomes Measurement Information System Global Health

  2. Oxford Hip Score

    Time frame: 2 years

  3. Oxford Knee Score

    Time frame: 2 years

  4. Musculoskeletal Health Questionnaire

    Time frame: 2 years

    MSK-HQ

  5. Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys

    Time frame: 2 years

    Perception of success/fulfilment of expectations

  6. Patient Health Questionnaire-4

    Time frame: 2 years

    PHQ-4

  7. 11-point Numerical Pain Rating Scale

    Time frame: 2 years

    Pain

  8. Pain Catastrophising Scale

    Time frame: 2 years

  9. Length of stay

    Time frame: 2 years

    Self-reported by study specific electronic questionnaire

  10. Activity

    Time frame: 2 years

    Levels of exercise and activity self-reported by study specific electronic questionnaire

  11. Return to work

    Time frame: 2 years

    Work status self-reported by electronic questionnaire using National Statistics Socio-economic Classification

  12. Readmission within 30 days

    Time frame: 30 days

  13. Surgical Site Infection

    Time frame: 2 years

  14. Periprosthetic Fracture

    Time frame: 2 years

  15. Dislocation

    Time frame: 2 years

  16. Revision/Re-operation

    Time frame: 2 years

  17. Mortality

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

William Fishley

CONTACT

[email protected]

01912934087

Sponsors and collaborators

Lead sponsor

Northumbria Healthcare NHS Foundation Trust

Other

Collaborators

  • University of York

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2030
Study completion
2031
First posted
Apr 24, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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