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Alberta Hip Improvement Project

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293774
First Posted: February 20, 2006
Last Update Posted: July 20, 2016
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.
Information provided by (Responsible Party):
Alberta Bone and Joint Health Institute
February 16, 2006
February 20, 2006
July 20, 2016
June 2004
January 2011   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00293774 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Alberta Hip Improvement Project
A Provincial Initiative to Examine the Efficacy, Cost-effectiveness and Long-term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip
A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.
This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Blood samples retained for cobalt and chromium metal ion level analysis on select cohort.
Probability Sample
Males between the ages of 18-65 and females between the ages of 18-55
Arthroplasty, Replacement, Hip
Not Provided
  • Standard
    Standard hip replacement subjects (polyethylene)
  • Alternative Bearing
    Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
September 2020
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • documentation of DJD of hip
  • patient at least 18 years
  • patient able to provide written consent
  • Male under 65 years, female under 56 years
  • Orthopedic surgeon has received appropriate training to implant an alternative device

Exclusion Criteria:

  • renal failure (MOM only)
  • child bearing potential (MOM only)
  • inappropriate femoral anatomy, including evidence of osteoporosis
  • inflammatory arthritis (MOM)
  • Unwilling to consent
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00293774
ABHIP-00001
Yes
Not Provided
Not Provided
Alberta Bone and Joint Health Institute
Alberta Bone and Joint Health Institute
Not Provided
Principal Investigator: James MacKenzie, M.D. University of Calgary
Principal Investigator: Greg O'Connor, MD University of Alberta
Alberta Bone and Joint Health Institute
July 2016