NCT05824845 QIST Collaborative - Arthroplasty Research Cohort (ARC) Study
| NCT ID | NCT05824845 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northumbria Healthcare NHS Foundation Trust |
| Condition | Hip Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-07-13 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2023-07-13 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05824845 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05824845 currently recruiting?
Yes, NCT05824845 is actively recruiting participants. Contact the research team at arcstudy@northumbria-healthcare.nhs.uk for enrollment information.
Where is the NCT05824845 trial being conducted?
This trial is being conducted at Ashington, United Kingdom.
Who is sponsoring the NCT05824845 clinical trial?
NCT05824845 is sponsored by Northumbria Healthcare NHS Foundation Trust. The trial plans to enroll 5,000 participants.