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Alberta Hip and Knee Replacement Project

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00277186
First Posted: January 16, 2006
Last Update Posted: July 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Alberta Medical Association
Calgary Health Region
David Thompson Health Region
Capital Health Region
Alberta Health & Wellness
Information provided by:
Alberta Bone and Joint Health Institute
  Purpose
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

Condition Intervention
Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Other: New Care Continuum

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

Resource links provided by NLM:


Further study details as provided by Alberta Bone and Joint Health Institute:

Primary Outcome Measures:
  • health related quality of life scores [ Time Frame: 3 month and 12 months post-surgery ]

Secondary Outcome 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 ]

Enrollment: 3434
Study Start Date: April 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277186


Locations
Canada, Alberta
Alberta Bone and Joint Health Institute
Calgary, Alberta, Canada, T2N 1Z6
Sponsors and Collaborators
Alberta Bone and Joint Health Institute
Alberta Medical Association
Calgary Health Region
David Thompson Health Region
Capital Health Region
Alberta Health & Wellness
Investigators
Principal Investigator: Cyril Frank, MD University of Calgary
Principal Investigator: Bill Johnston, MD University of Alberta
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alberta Bone and Joint Health Institute
ClinicalTrials.gov Identifier: NCT00277186     History of Changes
Other Study ID Numbers: ARTH-00001
First Submitted: January 13, 2006
First Posted: January 16, 2006
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Alberta Bone and Joint Health Institute:
Arthroplasty
Health services research
Intent to treat
Randomized
Controlled