Alberta Hip and Knee Replacement Project

Arthroplasty, Replacement, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277186
• Other study ID #: ARTH-00001
• Status: Completed
• Phase: N/A
• First received: January 13, 2006
• Last updated: July 28, 2008
• Start date: April 2005
• Est. completion date: May 2006

Study information

• Verified date: July 2008
• Source: Alberta Bone and Joint Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3434
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Bone and Joint Health Institute	Calgary	Alberta

Sponsors (6)

Lead Sponsor	Collaborator
Alberta Bone and Joint Health Institute	Alberta Health & Wellness, Alberta Medical Association, Calgary Health Region, Capital Health Region, David Thompson Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health related quality of life scores		3 month and 12 months post-surgery
Secondary	health resource utilization		3 month and 12 months post-surgery
Secondary	wait time		Pre-surgery
Secondary	safety		3 month and 12 months post-surgery
Secondary	cost utility		3 month and 12 months post-surgery
Secondary	patient satisfaction		3 month and 12 months post-surgery
Secondary	provider satisfaction		3 month and 12 months post-surgery