Alberta Hip Improvement Project

Arthroplasty, Replacement, Hip Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293774
• Other study ID #: ABHIP-00001
• Status: Completed
• Start date: June 2004
• Est. completion date: July 16, 2021

Study information

• Verified date: July 2021
• Source: Alberta Bone and Joint Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1632
• Est. completion date: July 16, 2021
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Locations

Country	Name	City	State
Canada	Alberta Bone and Joint Health Institute	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Bone and Joint Health Institute

Country where clinical trial is conducted

Canada,