The WHERE Study: Waiting for Hip and KneE REplacement

NCT06074900 | Recruiting

• 1 other identifier: 119349
• Study Type: observational
• Target: 3,008
• Locations: 1 country
• Sites: 1

Brief Summary

Total hip and knee replacements (TJR) for osteoarthritis are common orthopaedic procedures performed in Canada. Waits for these procedures are already common and lengthy, and the COVID-19 pandemic has resulted in the further of delay of thousands of scheduled TJRs. Longer wait times for TJR can be associated with increased pain and functional disability, and up to 80% of patients awaiting TJR use opioids for pain management. Further, pre-operative pain, functional disability and opioid use has been linked to worse recovery and continued opioid abuse post-operatively. Interestingly, some clinical studies have shown that not all patients experience a deterioration in symptoms while on the waitlist for TJR, and a longer wait time is not always associated with poor post-operative outcomes. However, there is insufficient evidence surrounding the relationships between wait time, patient characteristics, and outcomes both prior to and following hip or knee replacement. The Investigators aim to establish a large prospective cohort of patients with osteoarthritis waiting for TJR with key research questions and the overarching objectives of identifying which patients deteriorate while on the waitlist, and how wait time affects patient-important outcomes following surgery. The study will enroll 3008 patients awaiting TJR at 10 Centres from across Canada. All participating site investigators are fellowship trained Orthopaedic surgeons, working in acute care facilities with active research programs and dedicated research staff. The study will follow the patients from their waitlist enrolment up to two years post-operatively. During this time, the research team will collect pain, function, opioid use, and quality of life measures at regular intervals. In addition, an economic analysis will be conducted to determine the impact of length of time on a waitlist on patient and healthcare system costs. The data will highlight the consequences of long waits for patients undergoing TJR, information that will improve patient care and provide insight for refining wait list policies.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Keywords

TJR; Hip; Knee; Osteoarthiritis; Wait times; Total hip replacement; Total knee replacement

Outcome Measures

Primary Outcomes (1)

• Patient-reported pain and functional ability

  Patient-reported pain and functional ability, measured by the Hip/Knee Disability and Osteoarthritis, Joint Replacement scores (H/KOOS-JR).The H/KOOS-JR scores were developed specifically for patients with OA undergoing TJR, and have sufficient measurement properties in OA patients undergoing TJR when administered in person or via telephone.

  24 months

Secondary Outcomes (11)

• Prescription opioid use

  24 months

• Perceived disability

  24 months

• Social support

  24 months

• Health-related quality of life (HRQOL)

  24 months

• Physical Activity

  24 months

Interventions

prospective cohort study OTHER

This study is observational in nature and does not involve any experimental treatments or additional radiographs, diagnostic tests or clinical interventions beyond what is regularly prescribed within the context of standard of care for each patient. Outcomes for participants will be measured and captured primarily during regularly scheduled clinic/hospital visits, which include standard of care clinical examinations. Participants will be asked to complete study questionnaires as per the visit schedule and participant data will be recorded on applicable study CRFs at the appropriate time points. CRFs detailing patient, injury, and treatment variables of interested will be collected at the time of recruitment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with hip or knee OA booked for a surgical consult at the participating sites will be eligible for inclusion based on the above inclusion/exclusion criteria.

You may qualify if:

• Aged 18 years and older;
• Primary OA of the hip or knee (as defined by the American College of Rheumatology)60,61;
• Provision of informed consent

You may not qualify if:

• Hip or knee arthritis other than OA;
• Previous TJR or retained hardware on the ipsilateral side;
• Refusal to participate;
• Inability to provide informed consent;
• Likely to have problems maintaining follow-up in the opinion of the investigator (i.e. no fixed address, severe mental disorders or additions without adequate support
• Inability to speak or understand English without a registered interpreter

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Interventions

Prospective Studies

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 10, 2023
• Study Start: July 13, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)