Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138892
Status:
UNKNOWN
Last Update Posted:
2011-10-14
First Post:
2005-08-26
Brief Title:
A Randomized Controlled Trial of Long Versus Short Wait For Primary Total Hip and Knee Arthroplasty
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Randomized Controlled Trial of Long Versus Short Wait For Primary Total Hip and Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| V02-0186 | None | None | None |