Clinical trial NCT00277186: Alberta Hip and Knee Replacement Project
Official title: A Randomized Controlled Prospective Study to Examine the Effectiveness of a New Evidence Based Arthroplasty Care Model for Patients With Severe Degenerative Joint Disease (DJD) of the Hip or Knee in Alberta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Arthroplasty
Health services research
Intent to treat
Randomized
Controlled
Lead sponsor: Alberta Bone and Joint Health Institute
Sponsor class: OTHER
Collaborators: name: Alberta Medical Association
name: Calgary Health Region
name: David Thompson Health Region
name: Capital Health Region
name: Alberta Health & Wellness
First posted: 2006-01-16
Enrollment: 3434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine if a New Arthroplasty Care Model, established on evidence-based medicine and best practices, will improve patient outcomes and improve cost effectiveness for patients with severe degenerative joint disease of the hip or knee in Alberta

Detailed description: The Alberta Orthopaedic Society through its Arthroplasty Service Design Working Group has, after carefully reviewing the existing conventional approach to arthroplasty care, developed what they believe could be a much improved new evidence based arthroplasty care model. This model represents how ideally a patient would access and receive health services across the complete continuum of care. In addition, wherever possible, evidence gathered from the literature and from "known best practices" has been utilized to develop standards related to access, wait times, clinical quality, resource use and health outcome measures. Where no evidence or "known best practices" exist, a standard that best support achieving other known standards are being developed. This new evidence based arthroplasty model seeks to significantly minimize and where possible, eliminate all the current gaps and barriers to arthroplasty care.

This study will seek to prove that the new evidence based arthroplasty model will deliver improved patient outcomes with improved cost effectiveness. Once proven, it is anticipated that this new evidence based arthroplasty model will become the standard of care in Alberta, and a model for other jurisdictions to use in their health service re-designs

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is able to provide written consent

Exclusion Criteria:

* Patient has previously undergone arthroplasty of the same hip or knee (revision)
* Patient has a surgical date scheduled for arthroplasty
* Patient requires a hip resurfacing procedure or an oxford knee
* Patient has a concurrent medical condition that would contraindicate the patients' ability to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with an anticipated life expectancy of ≤ 2 years
* Patient has senile dementia or Alzheimer's disease

Primary outcomes:
measure: health related quality of life scores
timeFrame: 3 month and 12 months post-surgery
Secondary outcomes:
measure: health resource utilization
timeFrame: 3 month and 12 months post-surgery
measure: wait time
timeFrame: Pre-surgery
measure: safety
timeFrame: 3 month and 12 months post-surgery
measure: cost utility
timeFrame: 3 month and 12 months post-surgery
measure: patient satisfaction
timeFrame: 3 month and 12 months post-surgery
measure: provider satisfaction
timeFrame: 3 month and 12 months post-surgery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Bone and Joint Health Institute
state: Alberta
Study officials:
affiliation: University of Calgary
name: Cyril Frank, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Bill Johnston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gooch K, Marshall DA, Faris PD, Khong H, Wasylak T, Pearce T, Johnston DW, Arnett G, Hibbert J, Beaupre LA, Zernicke RF, Frank C. Comparative effectiveness of alternative clinical pathways for primary hip and knee joint replacement patients: a pragmatic randomized, controlled trial. Osteoarthritis Cartilage. 2012 Oct;20(10):1086-94. doi: 10.1016/j.joca.2012.06.017. Epub 2012 Jul 11.