A Randomized Controlled Trial of Long Versus Short Wait For Primary Total Hip and Knee Arthroplasty
2 other identifiers
interventional
236
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 26, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 14, 2011
October 1, 2011
10.2 years
August 26, 2005
October 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
lower-extremity function at 36 months post randomization as measured by the WOMAC functional dimension
36 months
Secondary Outcomes (1)
lower-extremity pain and stiffness at 36 months post randomization as measured by the WOMAC pain and stiffness dimension
36 months
Interventions
See Detailed Description.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- (1) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Garbuz, MD, MHSc
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2005
First Posted
August 30, 2005
Study Start
August 1, 2002
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 14, 2011
Record last verified: 2011-10