QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

Knee Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824845
• Other study ID #: ARC Study
• Status: Recruiting
• Start date: July 13, 2023
• Est. completion date: May 2031

Study information

• Verified date: July 2023
• Source: Northumbria Healthcare NHS Foundation Trust
• Contact: William Fishley
• Phone: 01912934087
• Email: arcstudy[@]northumbria-healthcare.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 2031
• Est. primary completion date: May 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Knee Arthritis

Intervention

Procedure:
• Hip/Knee Replacement
Hip/Knee Replacement

Locations

Country	Name	City	State
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Ashington

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria Healthcare NHS Foundation Trust	University of York

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EQ-5D-5L health-related quality of life score		2 years
Secondary	PROMIS-10	Patient-Reported Outcomes Measurement Information System Global Health	2 years
Secondary	Oxford Hip Score		2 years
Secondary	Oxford Knee Score		2 years
Secondary	Musculoskeletal Health Questionnaire	MSK-HQ	2 years
Secondary	Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys	Perception of success/fulfilment of expectations	2 years
Secondary	Patient Health Questionnaire-4	PHQ-4	2 years
Secondary	11-point Numerical Pain Rating Scale	Pain	2 years
Secondary	Pain Catastrophising Scale		2 years
Secondary	Length of stay	Self-reported by study specific electronic questionnaire	2 years
Secondary	Activity	Levels of exercise and activity self-reported by study specific electronic questionnaire	2 years
Secondary	Return to work	Work status self-reported by electronic questionnaire using National Statistics Socio-economic Classification	2 years
Secondary	Readmission within 30 days		30 days
Secondary	Surgical Site Infection		2 years
Secondary	Periprosthetic Fracture		2 years
Secondary	Dislocation		2 years
Secondary	Revision/Re-operation		2 years
Secondary	Mortality		2 years