NCT00277186

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,434

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

1.1 years

First QC Date

January 13, 2006

Last Update Submit

July 28, 2008

Conditions

Arthroplasty, Replacement, HipArthroplasty, Replacement, Knee

Keywords

ArthroplastyHealth services researchIntent to treatRandomizedControlled

Outcome Measures

Primary Outcomes (1)

  • health related quality of life scores

    3 month and 12 months post-surgery

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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

New Care ContinuumOTHER

Patient experience surgery through newly designed arthroplasty continuum

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is at least 18 years of age
  • Patient is able to provide written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Bone and Joint Health Institute

Calgary, Alberta, T2N 1Z6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22796513DERIVED

Study Officials

  • Cyril Frank, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Bill Johnston, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Study Start

April 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

CA(1)