RecruitingNCT05824845

QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

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


Sponsor

Northumbria Healthcare NHS Foundation Trust

Enrollment

5,000 participants

Start Date

Jul 13, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is building a large research database of patients in the UK who undergo elective hip or knee replacement surgery — a collaborative effort called the Arthroplasty Research Cohort (ARC) Study. The goal is to collect high-quality, standardized data on outcomes, recovery, and quality of life before and after joint replacement, which will serve as a foundation for future research and clinical trials comparing different surgical techniques, implants, and rehabilitation approaches. Any UK resident aged 18 or older who is scheduled for an elective primary hip or knee replacement (total hip replacement, total knee replacement, or unicompartmental knee replacement) is eligible. There are deliberately no exclusion criteria beyond the inclusion requirements, making this a broad, inclusive study designed to represent a wide range of real-world patients. Participants will complete questionnaires about their pain, function, and quality of life before and after surgery, and their data may be linked to NHS records for long-term follow-up. Joining also means being invited to participate in future clinical trials. This research is significant because joint replacement is one of the most common surgical procedures performed, yet there remain important unanswered questions about which patients benefit most, which implants last longest, and how best to optimize recovery. A large, well-organized cohort study like ARC will help answer these questions over time.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHip/Knee Replacement

Hip/Knee Replacement


Locations(1)

Northumbria Healthcare NHS Foundation Trust

Ashington, United Kingdom

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NCT05824845


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