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Alberta Hip Improvement Project

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.
ClinicalTrials.gov Identifier: NCT00293774
Recruitment Status : Active, not recruiting
First Posted : February 20, 2006
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Arthroplasty, Replacement, Hip

Detailed Description:
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

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2004
Primary Completion Date : January 2011
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Standard
Standard hip replacement subjects (polyethylene)
Alternative Bearing
Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Blood samples retained for cobalt and chromium metal ion level analysis on select cohort.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Males between the ages of 18-65 and females between the ages of 18-55
Criteria

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
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): NCT00293774


Locations
Canada, Alberta
Alberta Bone and Joint Health Institute
Calgary, Alberta, Canada, T2N 2X6
Sponsors and Collaborators
Alberta Bone and Joint Health Institute
Investigators
Principal Investigator: James MacKenzie, M.D. University of Calgary
Principal Investigator: Greg O'Connor, MD University of Alberta
More Information

Responsible Party: Alberta Bone and Joint Health Institute
ClinicalTrials.gov Identifier: NCT00293774     History of Changes
Other Study ID Numbers: ABHIP-00001
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Alberta Bone and Joint Health Institute:
Prospective
Conventional therapy
Registry
Metal-on-metal
Ceramic-on-ceramic
Hip Arthroplasty