Northumbria Healthcare NHS Foundation Trust
Ashington, United Kingdom
Location status: Recruiting
NCT Number: NCT05824845
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ashington, United Kingdom
Location status: Recruiting
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:
Exclusion criteria
Provided a participant meets all of the inclusion criteria, there are no exclusion criteria for the cohort study.
Hip/Knee Replacement
Time frame: 2 years
Time frame: 2 years
Patient-Reported Outcomes Measurement Information System Global Health
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
MSK-HQ
Time frame: 2 years
Perception of success/fulfilment of expectations
Time frame: 2 years
PHQ-4
Time frame: 2 years
Pain
Time frame: 2 years
Time frame: 2 years
Self-reported by study specific electronic questionnaire
Time frame: 2 years
Levels of exercise and activity self-reported by study specific electronic questionnaire
Time frame: 2 years
Work status self-reported by electronic questionnaire using National Statistics Socio-economic Classification
Time frame: 30 days
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Contact information is provided by the study sponsor or research team.
Northumbria Healthcare NHS Foundation Trust
Other
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
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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