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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthritis; Hip Arthritis
• Intervention / Treatment: Procedure: Hip/Knee Replacement

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: William Fishley; Phone Number: 01912934087; Email: arcstudy@northumbria-healthcare.nhs.uk

Study Locations

• United Kingdom
  • Ashington, United Kingdom
    • Recruiting
    • Northumbria Healthcare NHS Foundation Trust
    • Contact: William Fishley; Phone Number: 01912934087; Email: arcstudy@northumbria-healthcare.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

UK Residents age 18 years or over undergoing elective primary hip or knee replacement

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARC Study Cohort	Procedure: Hip/Knee Replacement; Hip/Knee Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
EQ-5D-5L health-related quality of life score	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		2 years
Oxford Knee Score		2 years
Oxford Hip Score		2 years
PROMIS-10	Patient-Reported Outcomes Measurement Information System Global Health	2 years
Musculoskeletal Health Questionnaire	MSK-HQ	2 years
Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys	Perception of success/fulfilment of expectations	2 years
Patient Health Questionnaire-4	PHQ-4	2 years
11-point Numerical Pain Rating Scale	Pain	2 years
Pain Catastrophising Scale		2 years
Length of stay	Self-reported by study specific electronic questionnaire	2 years
Activity	Levels of exercise and activity self-reported by study specific electronic questionnaire	2 years
Return to work	Work status self-reported by electronic questionnaire using National Statistics Socio-economic Classification	2 years
Readmission within 30 days		30 days
Surgical Site Infection		2 years
Periprosthetic Fracture		2 years
Dislocation		2 years
Revision/Re-operation		2 years

Collaborators and Investigators

• Sponsor: Northumbria Healthcare NHS Foundation Trust
• Collaborators: University of York

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hip Replacement; Knee Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: ARC Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No