OsteoarthritisPhase 4NCT00138892
A Randomized Controlled Trial of Long Versus Short Wait For Primary Total Hip and Knee Arthroplasty
A Phase 4 study testing Waiting time (access time to Total joint replacement) in people with Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
The primary research question is: Does expedited hip and knee replacement result in improved lower-extremity function at 36 months post randomization as measured by the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)? A secondary component to this question is whether expedited surgery improves pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Waiting time (access time to Total joint replacement)
- Type of treatment
- Surgery or procedure
- How many people
- 236 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2002to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- All candidates for primary total hip and knee arthroplasty with a diagnosis of osteoarthritis or a¬vascular necrosis. Osteoarthritis is defined by the ACR clinical classification criteria for OA of the hip and knee. , (see Appendix, Table 3, ACR Clinical Classification Criteria). Urgency is not assessed since there are no valid criteria available.
Who cannot join
- Unwillingness to have surgery within 1-2 months, (2) Previous arthroplasty to the index joint, (3) inflammatory arthritis, (4) indications for arthroplasty in >1 joint (any combination of hip or knee, primary or revision) (5) inability to respond to a questionnaire in English.
Trial locations and contacts
1 site in 1 country.
About this study
The primary research question is: Does expedited hip and knee replacement result in improved lower-extremity function at 36 months post randomization as measured by the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)? A secondary component to this question is whether expedited surgery improves pain and stiffness scores as measured by the WOMAC and generic QOL as measured by the Medical Outcomes Study Short-Form 36 (SF-36) and Health Utilities Index Mark 3 (HUI3)? Secondary questions are: Does joint-specific and generic QOL deteriorate significantly during waiting? Does prolonged waiting increase the economic cost associated with hip and knee arthroplasty? And does expedited surgery have an effect on patient satisfaction with major joint replacement?
Read the detailed description
Background Long waiting times for certain medical, diagnostic and surgical procedures are the result of high demand for relatively scarce resources. Most western countries have established queues for elective procedures and consultations. Among elective surgical procedures, total hip and knee replacements have the longest waiting lists, twice as long as waits for elective cardiovascular and eye surgery. The data on waiting lists are not highly reliable, nevertheless it is clear that in British Columbia the wait for hip and knee arthroplasty grew from 2 months 1995 to 6 months in 1999 and that a similar increase took place in Ontario. At Vancouver Hospital the median wait for these procedures over the past year has been 7-8 months. Patients are not usually considered candidates for hip or knee replacement until pain and dysfunction have become severe. But waiting prolongs dysfunction and pain that already warrant surgery. A number of studies have demonstrated the burden of suffering that could be relieved by short waits. The question of whether and how much prompt access to surgery could benefit our patients over the long term has attracted very little research. A study we are proposing will for the first time directly address the short- and long-term benefit of expedited surgery with patient-based measures and economic costs, and will do so using valid reliable methods and instruments so that its results can be clearly understood and widely accepted.
Objectives The primary research question is: Does expedited hip and knee replacement result in improved lower-extremity function at 36 months post randomization as measured by the WOMAC functional dimension? A secondary component to the functional question is whether expedited surgery improves pain and stiffness scores as measured by WOMAC and generic quality of life (QOL) as measured by SF-36 and HUI3? Secondary questions are: Does joint-specific and generic QOL deteriorate significantly during waiting? Does prolonged waiting increase the economic cost associated with hip and knee arthroplasty? And does expedited surgery have an effect on patient satisfaction with major joint replacement? Hypothesis Reducing waiting time may improve patient outcomes. This is biologically plausible that prolonging the arthritic process in these joints may result in muscle atrophy, tissue contractures and deterioration of general medical condition that may not be fully recoverable post-surgery. There is some evidence for the harm concurrent with waiting but none for its deleterious long-term effects on hip and knee replacement patients. Our hypothesis is that prolonged waiting is a significant independent risk factor for reduced long-term benefit following surgery. Our secondary hypothesis is that prolonged waiting for hip and knee arthroplasty increases the total economic cost associated with treatment of these disorders.
Research plan The plan involves a randomized controlled clinical trial assigning joint replacement candidates to either a 1-2 month wait or a 7-8 month wait. We will ask patients on both waiting lists to complete QOL and economic assessment questionnaires at the start of waiting, the end of waiting and every six months for 36 months post randomization. Outcome measures will be the WOMAC, the Oxford 12-Item Hip and Knee score, the SF-36, the HUI3, resource utilization information drawn from patient questionnaires and administrative databases, and a measure of patient satisfaction. The analysis will use univariate and multivariate predictive models. In addition we will be assess health trajectories and relative utilization costs.
- Conditions
- Osteoarthritis
- Being tested
- Waiting time (access time to Total joint replacement)
- Keywords
- Quality of life, waiting time, total joint replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waiting time (access time to Total joint replacement)Procedure or surgery
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
lower-extremity function at 36 months post randomization as measured by the WOMAC functional dimension
Measured: 36 months
Secondary outcomes (1)
lower-extremity pain and stiffness at 36 months post randomization as measured by the WOMAC pain and stiffness dimension
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startAug 2002
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald Garbuz, MD, MHSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138892
- Sponsor's protocol ID
- C01-0407
- Other IDs
- V02-0186
- Status last verified
- Oct 2011
- First submitted
- 26 Aug 2005
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Long Versus Short Wait For Primary Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00138892
- Acronym / sponsor ID
- C01-0407
- Conditions
- Osteoarthritis
- Keywords
- Quality of life, waiting time, total joint replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 30 Aug 2005 (estimated)
- 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.
The primary research question is: Does expedited hip and knee replacement result in improved lower-extremity function at 36 months post randomization as measured by the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)? A secondary component to this question is whether expedited surgery improves pain and stiffness scores as measured by the WOMAC and generic QOL as measured by the Medical Outcomes Study Short-Form 36 (SF-36) and Health Utilities Index Mark 3 (HUI3)? Secondary questions are: Does joint-specific and generic QOL deteriorate significantly during waiting? Does prolonged waiting increase the economic cost associated with hip and knee arthroplasty? And does expedited surgery have an effect on patient satisfaction with major joint replacement?
Detailed description
Background Long waiting times for certain medical, diagnostic and surgical procedures are the result of high demand for relatively scarce resources. Most western countries have established queues for elective procedures and consultations. Among elective surgical procedures, total hip and knee replacements have the longest waiting lists, twice as long as waits for elective cardiovascular and eye surgery. The data on waiting lists are not highly reliable, nevertheless it is clear that in British Columbia the wait for hip and knee arthroplasty grew from 2 months 1995 to 6 months in 1999 and that a similar increase took place in Ontario. At Vancouver Hospital the median wait for these procedures over the past year has been 7-8 months. Patients are not usually considered candidates for hip or knee replacement until pain and dysfunction have become severe. But waiting prolongs dysfunction and pain that already warrant surgery. A number of studies have demonstrated the burden of suffering that could be relieved by short waits. The question of whether and how much prompt access to surgery could benefit our patients over the long term has attracted very little research. A study we are proposing will for the first time directly address the short- and long-term benefit of expedited surgery with patient-based measures and economic costs, and will do so using valid reliable methods and instruments so that its results can be clearly understood and widely accepted.
Objectives The primary research question is: Does expedited hip and knee replacement result in improved lower-extremity function at 36 months post randomization as measured by the WOMAC functional dimension? A secondary component to the functional question is whether expedited surgery improves pain and stiffness scores as measured by WOMAC and generic quality of life (QOL) as measured by SF-36 and HUI3? Secondary questions are: Does joint-specific and generic QOL deteriorate significantly during waiting? Does prolonged waiting increase the economic cost associated with hip and knee arthroplasty? And does expedited surgery have an effect on patient satisfaction with major joint replacement? Hypothesis Reducing waiting time may improve patient outcomes. This is biologically plausible that prolonging the arthritic process in these joints may result in muscle atrophy, tissue contractures and deterioration of general medical condition that may not be fully recoverable post-surgery. There is some evidence for the harm concurrent with waiting but none for its deleterious long-term effects on hip and knee replacement patients. Our hypothesis is that prolonged waiting is a significant independent risk factor for reduced long-term benefit following surgery. Our secondary hypothesis is that prolonged waiting for hip and knee arthroplasty increases the total economic cost associated with treatment of these disorders.
Research plan The plan involves a randomized controlled clinical trial assigning joint replacement candidates to either a 1-2 month wait or a 7-8 month wait. We will ask patients on both waiting lists to complete QOL and economic assessment questionnaires at the start of waiting, the end of waiting and every six months for 36 months post randomization. Outcome measures will be the WOMAC, the Oxford 12-Item Hip and Knee score, the SF-36, the HUI3, resource utilization information drawn from patient questionnaires and administrative databases, and a measure of patient satisfaction. The analysis will use univariate and multivariate predictive models. In addition we will be assess health trajectories and relative utilization costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All candidates for primary total hip and knee arthroplasty with a diagnosis of osteoarthritis or a¬vascular necrosis. Osteoarthritis is defined by the ACR clinical classification criteria for OA of the hip and knee. , (see Appendix, Table 3, ACR Clinical Classification Criteria). Urgency is not assessed since there are no valid criteria available.
Key exclusion criteria (1 listed)
- Unwillingness to have surgery within 1-2 months, (2) Previous arthroplasty to the index joint, (3) inflammatory arthritis, (4) indications for arthroplasty in >1 joint (any combination of hip or knee, primary or revision) (5) inability to respond to a questionnaire in English.
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 |
|---|---|---|
| Waiting time (access time to Total joint replacement)See Detailed Description. | Procedure or surgery | – |
Primary outcome
lower-extremity function at 36 months post randomization as measured by the WOMAC functional dimension
Time frame: 36 months
1 secondary outcome
lower-extremity pain and stiffness at 36 months post randomization as measured by the WOMAC pain and stiffness dimension
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2011.
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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. This study is not recruiting at the moment.
Donald Garbuz, MD, MHSc principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Waiting time (access time to Total joint replacement) in people with Osteoarthritis, run by University of British Columbia 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Oct 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower-extremity function at 36 months post randomization as measured by the WOMAC functional dimension (time frame: 36 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 14 Oct 2011.