Recruiting

Observational Study

Sponsor:

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

Code:

NCT06074900

Conditions

Hip Osteoarthritis

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

prospective cohort study

Study Details

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

Study ID

NCT06074900

Start date

Jul 13, 2023

Status verified date

Mar, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Hip or knee arthritis other than OA;
2. Previous TJR or retained hardware on the ipsilateral side;
3. Refusal to participate;
4. Inability to provide informed consent;
5. 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
6. Inability to speak or understand English without a registered interpreter

Study Design

Enrollment

3008 participants

Anticipated

Interventions and Outcome Measures

Interventions

prospective cohort study

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.

Primary outcome measure

  • Patient-reported pain and functional ability [ Time Frame: 24 months ]

Central Contacts and Locations

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

Lawson Health Research Institute

519-685-8500

Principal Investigator:

Emil Schemitsch, MD FRCS(C)

More Information

Sponsor

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

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-03-11.