Alberta Hip Improvement Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2010 by Alberta Bone and Joint Health Institute
Sponsor:
Information provided by:
Alberta Bone and Joint Health Institute
ClinicalTrials.gov Identifier:
NCT00293774
First received: February 16, 2006
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

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 Phase
Arthroplasty, Replacement, Hip
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alberta Bone and Joint Health Institute:

Biospecimen Retention:   Samples Without DNA

Blood samples retained for cobalt and chromium metal ion level analysis on select cohort.


Estimated Enrollment: 1000
Study Start Date: June 2004
Estimated Study Completion Date: September 2014
Groups/Cohorts
Standard
Standard hip replacement subjects (polyethylene)
Alternative Bearing
Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293774

Contacts
Contact: Robyn Parker 430-670-0886 info@albertaboneandjoint.com
Contact: Peter Faris 403-670-0886 info@albertaboneandjoint.com

Locations
Canada, Alberta
Alberta Bone and Joint Health Institute Recruiting
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

No publications provided

Responsible Party: Alberta Bone and Joint Health Insitute
ClinicalTrials.gov Identifier: NCT00293774     History of Changes
Other Study ID Numbers: ABHIP-00001
Study First Received: February 16, 2006
Last Updated: May 25, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014