Alberta Hip Improvement Project

Sponsor

Alberta Bone and Joint Health Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00293774

Collaborator

(none)

1,632

Enrollment

Location

205.5

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Actual Enrollment :

1632 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 :

Jun 1, 2004

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jul 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Standard Standard hip replacement subjects (polyethylene)
Alternative Bearing Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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