Alberta Hip and Knee Replacement Project | NCT00277186

Studies
Alberta Hip and Knee Replacement Project

NCT00277186

Sponsor

Alberta Bone and Joint Health Institute

Status

Completed

Last Update Posted

Jul 29, 2008Estimated

Enrollment

3,434Actual

Phase

Not Applicable

Conditions

Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee

Interventions

New Care Continuum

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Jan 13, 2006

First Submission Date that Met QC Criteria

Jan 13, 2006

First Posted Date

Jan 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2008

Last Update Posted Date

Jul 29, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Alberta Bone and Joint Health InstituteOTHER

Collaborators

Name	Class
Alberta Medical Association	OTHER
Calgary Health Region	OTHER
David Thompson Health Region	UNKNOWN
Capital Health Region

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,434Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Patients entering new care continuum	Other: New Care Continuum
Control	Active Comparator	Patient enter existing conventional approach	Other: New Care Continuum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
New Care Continuum	Other	Patient experience surgery through newly designed arthroplasty continuum	Control Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
health resource utilization		3 month and 12 months post-surgery
wait time		Pre-surgery
safety

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cyril Frank, MD	University of Calgary	Principal Investigator
Bill Johnston, MD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alberta Bone and Joint Health Institute		Calgary	Alberta	T2N 1Z6	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22796513	Derived	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.