Alberta Hip Improvement Project

NCT ID: NCT00293774

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1632 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2021-07-16

Brief Summary

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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.

Detailed Description

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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

Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard

Standard hip replacement subjects (polyethylene)

No interventions assigned to this group

Alternative Bearing

Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Bone and Joint Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James MacKenzie, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Greg O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Alberta Bone and Joint Health Institute

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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ABHIP-00001

Identifier Type: -

Identifier Source: org_study_id

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