QIST Collaborative - Arthroplasty Research Cohort (ARC) Study

NCT ID: NCT05824845

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2031-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Arthritis Knee Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARC Study Cohort

Hip/Knee Replacement

Intervention Type PROCEDURE

Hip/Knee Replacement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hip/Knee Replacement

Hip/Knee Replacement

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of York

OTHER

Sponsor Role collaborator

Northumbria Healthcare NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northumbria Healthcare NHS Foundation Trust

Ashington, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

William Fishley

Role: CONTACT

01912934087

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

William Fishley

Role: primary

01912934087

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARC Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Knee Arthroplasty Registry
NCT01132365 UNKNOWN