Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, hip
Phase phase 4
Sponsor Alberta Bone and Joint Health Institute
Start date June 2004
End date January 2011
Trial size 1000 participants
Trial identifier NCT00293774, ABHIP-00001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Standard hip replacement subjects (polyethylene)
Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator James MacKenzie, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alberta Bone and Joint Health Institute.