Alberta Hip and Knee Replacement Project

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

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Other: New Care Continuum

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

• Study Type: Interventional
• Enrollment (Actual): 3434
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1Z6
      • Alberta Bone and Joint Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Patients entering new care continuum	Other: New Care Continuum; Patient experience surgery through newly designed arthroplasty continuum
Active Comparator: Control; Patient enter existing conventional approach	Other: New Care Continuum; Patient experience surgery through newly designed arthroplasty continuum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
health related quality of life scores	3 month and 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
health resource utilization	3 month and 12 months post-surgery
wait time	Pre-surgery
safety	3 month and 12 months post-surgery
cost utility	3 month and 12 months post-surgery
patient satisfaction	3 month and 12 months post-surgery
provider satisfaction	3 month and 12 months post-surgery

Collaborators and Investigators

• Sponsor: Alberta Bone and Joint Health Institute
• Collaborators: Alberta Health & Wellness; Calgary Health Region; Alberta Medical Association; David Thompson Health Region; Capital Health Region
• Investigators: Principal Investigator: Cyril Frank, MD, University of Calgary; Principal Investigator: Bill Johnston, MD, University of Alberta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: January 13, 2006
• First Submitted That Met QC Criteria: January 13, 2006
• First Posted (Estimate): January 16, 2006

Study Record Updates

• Last Update Posted (Estimate): July 29, 2008
• Last Update Submitted That Met QC Criteria: July 28, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Arthroplasty; Randomized; Health services research; Controlled; Intent to treat
• Other Study ID Numbers: ARTH-00001