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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 1632

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2X6
      • Alberta Bone and Joint Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Males between the ages of 18-65 and females between the ages of 18-55

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): July 16, 2021

Study Registration Dates

• First Submitted: February 16, 2006
• First Submitted That Met QC Criteria: February 16, 2006
• First Posted (Estimate): February 20, 2006

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Registry; Hip Arthroplasty; Prospective; Conventional therapy; Metal-on-metal; Ceramic-on-ceramic
• Other Study ID Numbers: ABHIP-00001