Hip OsteoarthritisWHERENCT06074900
The WHERE Study: Waiting for Hip and KneE REplacement
An observational study of Hip Osteoarthritis and Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- prospective cohort study
- How many people
- 3,008 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jul 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A5W9
Lawson Health Research Institute, 519-685-8500
Emil Schemitsch, MD FRCS(C)
About this study
Official title: The WHERE Study: Waiting for Hip and KneE REplacement - A Prospective Cohort
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.
Read the detailed description
Understanding the association between sex, gender, SED (socioeconomic deprivation) PD (psychological distress), and the use of NSIs (non- surgical interventions) with distinct trajectories of deterioration prior to TJR, and the interactions between these variables, wait time, and post-operative recovery could help identify patient groups with the greatest unmet needs, and develop appropriate care plans. Effective waitlist management requires tracking the flow of patients as they progress toward surgery to identify patients at high or low risk of deterioration. Identifying those who require enhanced support while awaiting TJR, as well as delineating the relationship between wait time and post-operative outcomes within trajectory subgroups will enable targeted, patient-centered care. Managing waitlists for TJR based on evidence-based, clinically informative subgroups could eliminate inefficiencies and inequities in decision making and smooth the flow of patients. For these reasons, we aim to establish WHERE, the first prospective longitudinal study of patients awaiting TJR with the overarching objective of identifying which patients are most affected by longer waits, and how inequities affect the progression of symptoms prior-to, and recovery following TJR.
Managing waitlists for TJR based on evidence-based, clinically informative subgroups could eliminate inefficiencies and inconsistencies in decision making and smooth the flow of patients. For these reasons, the Investigators aim to establish WHERE, the first prospective cohort study of patients awaiting TJR with targeted research questions, and the overarching objective of identifying which patients deteriorate while on the waitlist and which patients may tolerate longer wait times.
WHERE will be the first prospective study to investigate distinct group-based trajectories of pre-operative pain, functional ability, opioid use, and health resource utilization (HRU) and their association with TJR patient characteristics and post-operative recovery and outcomes. The data collected will outline complex associations between delivery of care and symptoms in a representative setting, identify where performance improvement efforts need to be targeted, allow better identification and treatment of high-risk subgroups, and help set the foundation for creating improved, risk-stratified care pathways.
We have identified the following research questions as priorities to address with the WHERE cohort:
- What factors are associated with different trajectories of preoperative symptoms and opioid use in patients awaiting TJR? There is a paucity of evidence surrounding the trajectory of pre-operative symptoms and functional ability in patients with end-stage OA awaiting TJR, and how these may differ by SED or psychological variables. Study Aims:
- Determine whether previously identified trajectories of OA symptom progression are reproducible in patients scheduled for TJR in Canada; ii) Describe the relationships between SED and psychological variables with trajectory membership; iii) Identify time points in each sub-group where trajectories significantly change.
- Could targeted NSIs improve symptom management for patients waiting for TJR? Some patients awaiting TJR may not experience a significant deterioration in symptoms, and as many as 50% of patients undergoing TJR may not be appropriate surgical candidates, suggesting they could benefit from further NSIs prior to being scheduled for TJR. Study Aims:
- Characterize variation in the use of NSIs prior to TJR; ii) Identify which NSI types alleviate symptoms while awaiting TJR to inform symptom management programs; iii) Determine whether sex, gender, SED, or PD are associated with the use of, barriers to, and satisfaction with NSIs.
- Is the association between wait time and postoperative outcomes modified by trajectory group? Differences in the progression of symptoms while awaiting TJR may contribute to the inconsistent evidence surrounding the relationship between wait time and postoperative outcomes. Study Aims:
- Determine how longer wait times impact post-TJR outcomes in different trajectory groups; ii) Identify wait time thresholds within sub-groups to establish evidence-based targets.
- Does variation in symptom progression, functional deterioration, and opioid use while on the waitlist affect the cost-effectiveness of TJR? No studies have evaluated the cost-effectiveness of TJR for patients with different trajectories of pre-operative pain, functional ability, and opioid use, or the cost-effectiveness of TJR using evidence-based, patient-centered wait time cut-offs.
Study Aims:
- Provide insight into the association between variable pre-operative symptom trajectories and health-care system costs; ii) Examine the association between patient-centered wait time thresholds within trajectory sub-groups and health-care system costs following TJR.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- prospective cohort study
- Keywords
- TJR, Hip, Knee, Osteoarthiritis, Wait times, Total hip replacement, Total knee replacement
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective cohort studyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (11)
Prescription opioid use
Measured via the Narcotics Monitoring System
Measured: 24 months
Perceived disability
Measured via the Pain Disability Questionnaire.
Measured: 24 months
Social support
Measured via the modified Medical Outcomes Study-Social Support Scale (MOS-SSS).
Measured: 24 months
Health-related quality of life (HRQOL)
Measured using the patient-reported EuroQol-5D-5L (EQ5D) score.
Measured: 24 months
Physical Activity
Measured via the International Physical Activity Questionnaire short form.
Measured: 24 months
Health Services Utilization (HSU) and costs
Measured using the patient-reported Ambulatory and Home Care Record (AHCR), which assesses the total cost of illness from a societal perspective, and has very high agreement with administrative HSU. In addition, we will obtain administrative HSU and cost data from the databases at the Institute for Clinical Evaluative Sciences (ICES). Costs will include all costs incurred to the Ministry of Health and Long-Term Care (MoHLTC).
Measured: 24 months
Behavioral Pain
Collected via the Chronic Pain Behavioral Pain Scale (CPBPs), an objective pain scale developed to mitigate over-exaggeration in self-reported pain
Measured: 12 and 24 months
Patient global assessment of health
Collected via a validated Visual Analog Scale (0 = very poor health).
Measured: 12 and 24 months
Patient Satisfaction
Via a valid and reliable patient-reported measure that evaluates patients' satisfaction with their TJR. This measure considers pain relief, ability to do house/yard work or recreational activities, as well as overall satisfaction and how TJR improved their quality of life.
Measured: 12 and 24 months
Clinical outcomes (Radiographic and Performance).
Measured and recorded by a trained, independent assessor where possible, including:
- Radiographic: Radiolucencies, wear and osteolysis, component loosening, instability, or heterotopic ossification.
- Performance: The OMERACT-OARSI recommended timed up and go test (TUG), which valid and reliable for patients with hip and knee OA
Measured: 12 and 24 months
Complications
Including those detected radiographically (listed above), infection, leg length discrepancy, instability and dislocation, peri-prosthetic fracture, or any re-operations.
Measured: As needed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start13 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,008 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074900
- Sponsor's protocol ID
- 119349
- Acronym
- WHERE
- Status last verified
- Mar 2025
- First submitted
- 18 Oct 2021
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WHERE Study: Waiting for Hip and KneE REplacement - A Prospective Cohort
- ClinicalTrials.gov ID
- NCT06074900
- Acronym / sponsor ID
- WHERE / 119349
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Keywords
- TJR, Hip, Knee, Osteoarthiritis, Wait times, Total hip replacement, Total knee replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,008 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Understanding the association between sex, gender, SED (socioeconomic deprivation) PD (psychological distress), and the use of NSIs (non- surgical interventions) with distinct trajectories of deterioration prior to TJR, and the interactions between these variables, wait time, and post-operative recovery could help identify patient groups with the greatest unmet needs, and develop appropriate care plans. Effective waitlist management requires tracking the flow of patients as they progress toward surgery to identify patients at high or low risk of deterioration. Identifying those who require enhanced support while awaiting TJR, as well as delineating the relationship between wait time and post-operative outcomes within trajectory subgroups will enable targeted, patient-centered care. Managing waitlists for TJR based on evidence-based, clinically informative subgroups could eliminate inefficiencies and inequities in decision making and smooth the flow of patients. For these reasons, we aim to establish WHERE, the first prospective longitudinal study of patients awaiting TJR with the overarching objective of identifying which patients are most affected by longer waits, and how inequities affect the progression of symptoms prior-to, and recovery following TJR.
Managing waitlists for TJR based on evidence-based, clinically informative subgroups could eliminate inefficiencies and inconsistencies in decision making and smooth the flow of patients. For these reasons, the Investigators aim to establish WHERE, the first prospective cohort study of patients awaiting TJR with targeted research questions, and the overarching objective of identifying which patients deteriorate while on the waitlist and which patients may tolerate longer wait times.
WHERE will be the first prospective study to investigate distinct group-based trajectories of pre-operative pain, functional ability, opioid use, and health resource utilization (HRU) and their association with TJR patient characteristics and post-operative recovery and outcomes. The data collected will outline complex associations between delivery of care and symptoms in a representative setting, identify where performance improvement efforts need to be targeted, allow better identification and treatment of high-risk subgroups, and help set the foundation for creating improved, risk-stratified care pathways.
We have identified the following research questions as priorities to address with the WHERE cohort:
- What factors are associated with different trajectories of preoperative symptoms and opioid use in patients awaiting TJR? There is a paucity of evidence surrounding the trajectory of pre-operative symptoms and functional ability in patients with end-stage OA awaiting TJR, and how these may differ by SED or psychological variables. Study Aims:
- Determine whether previously identified trajectories of OA symptom progression are reproducible in patients scheduled for TJR in Canada; ii) Describe the relationships between SED and psychological variables with trajectory membership; iii) Identify time points in each sub-group where trajectories significantly change.
- Could targeted NSIs improve symptom management for patients waiting for TJR? Some patients awaiting TJR may not experience a significant deterioration in symptoms, and as many as 50% of patients undergoing TJR may not be appropriate surgical candidates, suggesting they could benefit from further NSIs prior to being scheduled for TJR. Study Aims:
- Characterize variation in the use of NSIs prior to TJR; ii) Identify which NSI types alleviate symptoms while awaiting TJR to inform symptom management programs; iii) Determine whether sex, gender, SED, or PD are associated with the use of, barriers to, and satisfaction with NSIs.
- Is the association between wait time and postoperative outcomes modified by trajectory group? Differences in the progression of symptoms while awaiting TJR may contribute to the inconsistent evidence surrounding the relationship between wait time and postoperative outcomes. Study Aims:
- Determine how longer wait times impact post-TJR outcomes in different trajectory groups; ii) Identify wait time thresholds within sub-groups to establish evidence-based targets.
- Does variation in symptom progression, functional deterioration, and opioid use while on the waitlist affect the cost-effectiveness of TJR? No studies have evaluated the cost-effectiveness of TJR for patients with different trajectories of pre-operative pain, functional ability, and opioid use, or the cost-effectiveness of TJR using evidence-based, patient-centered wait time cut-offs.
Study Aims:
- Provide insight into the association between variable pre-operative symptom trajectories and health-care system costs; ii) Examine the association between patient-centered wait time thresholds within trajectory sub-groups and health-care system costs following TJR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prospective cohort studyThis 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. | Other | – |
Primary outcome
Patient-reported pain and functional ability
Time frame: 24 months
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.
11 secondary outcomes
Prescription opioid use
Time frame: 24 months
Perceived disability
Time frame: 24 months
Social support
Time frame: 24 months
Health-related quality of life (HRQOL)
Time frame: 24 months
Physical Activity
Time frame: 24 months
Health Services Utilization (HSU) and costs
Time frame: 24 months
Behavioral Pain
Time frame: 12 and 24 months
Patient global assessment of health
Time frame: 12 and 24 months
Patient Satisfaction
Time frame: 12 and 24 months
Clinical outcomes (Radiographic and Performance).
Time frame: 12 and 24 months
Complications
Time frame: As needed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported pain and functional ability (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.