NCT05824845

Brief 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. 1.To evaluate outcomes following hip and knee replacements.
  2. 2.To determine risk factors for adverse outcomes in primary hip and knee replacements.
  3. 3.To identify targets for future research and intervention in patients undergoing primary hip and knee replacements
  4. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jul 2023May 2031

First Submitted

Initial submission to the registry

March 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

6.8 years

First QC Date

March 23, 2023

Last Update Submit

November 14, 2024

Conditions

Hip ArthritisKnee Arthritis

Keywords

Hip ReplacementKnee Replacement

Outcome Measures

Primary Outcomes (1)

  • EQ-5D-5L health-related quality of life score

    2 years

Secondary Outcomes (17)

  • PROMIS-10

    2 years

  • Oxford Hip Score

    2 years

  • Oxford Knee Score

    2 years

  • Musculoskeletal Health Questionnaire

    2 years

  • Hospital for Special Surgery Hip/Knee Replacement Expectations Surveys

    2 years

  • +12 more secondary outcomes

Study Arms (1)

ARC Study Cohort

Procedure: Hip/Knee Replacement

Interventions

Hip/Knee ReplacementPROCEDURE

Hip/Knee Replacement

ARC Study Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • Provides the necessary consents relating to data collection and use of study data, data linkage, future research and invitation to involvement in future trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria Healthcare NHS Foundation Trust

Ashington, United Kingdom

RECRUITING

Central Study Contacts

William Fishley

CONTACT

01912934087arcstudy@northumbria-healthcare.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 24, 2023

Study Start

July 13, 2023

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2031

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)