Alberta Hip and Knee Replacement Project

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2006

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

Interventions

  • Other: New Care Continuum
    • Patient experience surgery through newly designed arthroplasty continuum

Arms, Groups and Cohorts

  • Active Comparator: Intervention
    • Patients entering new care continuum
  • Active Comparator: Control
    • Patient enter existing conventional approach

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alberta Bone and Joint Health Institute
  • Collaborator
    • Alberta Medical Association
  • Provider of Information About this Clinical Study
    • Alberta Bone and Joint Health Institute, Alberta Bone and Joint Health Institute
  • Overall Official(s)
    • Cyril Frank, MD, Principal Investigator, University of Calgary
    • Bill Johnston, MD, Principal Investigator, University of Alberta

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