At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Hip/Knee Replacement (procedure)
- How long the study runs
- Study runs about 94 months (dates as stated)
- About the drug or intervention
- Hip/Knee Replacement — procedure: Hip/Knee Replacement
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 5,000
- Started
- 2023-07-13
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for hip arthritis
- • Clinical study - 5,000 participants
- • The ARC Study is a national observational cohort study to investigate patient reported and clinical outcomes after hip and knee replacements
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hip arthritis
Where?
- • Ashington - Northumbria Healthcare NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.
See the full criteria
Where Is This Study? (1 UK site)
Northumbria Healthcare NHS Foundation Trust
Ashington, United Kingdom
How to Get in Touch
William Fishley
Sponsor contactCONTACT