NCT00380549

A Comparison of an Advanced Metal Hip System to a Resurfacing Hip System

A Prospective Case Series (Pilot Study) Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Type Hip System With BFH™ Technology to the CONSERVE® Plus Total Hip Resurfacing System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes between patients who receive the CONSERVE® A-Class Total Hip compared to those who have received the CONSERVE® Plus Total Resurfacing Hip System.

Detailed description

A standard hip replacement involves replacing your hip joint with several parts: the cup which forms the socket in the pelvis; a head that forms a new ball for the top of the thigh bone; and a stem which is placed into the thigh bone. Typically, the socket is made out of metal and plastic, and the ball and stem are made out of metal. Recently, new metal-on-metal hip replacement systems have been developed where both the socket and the shell are made out of metal. This can cause metal ions to be released into the body. The CONSERVE® A-Class Total Hip with BFH technology is a new metal-on-metal total hip system which utilizes a large diameter femoral head (36-54 mm) more similar to the size of the original head (i.e., your original bone). Further, this system utilizes an advanced metal design which wears at a slower rate than typical metal-on-metal implants. Therefore, the primary purpose of the current study is to investigate if the CONSERVE® A-Class Total Hip with BFH technology will lead to lower blood ion levels in patients, as compared to patients in a recent study who received the CONSERVE® Plus Total Resurfacing Hip System, another metal-on-metal device. We are also comparing functional and radiographic (x-rays) outcomes between patients who receive the CONSERVE® A-Class Total Hip compared to those who have received the CONSERVE® Plus Total Resurfacing Hip System.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood ion levels	Blood ion levels or the levels of cobalt and chromium ions in the blood and urine will be analyzed.

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2006-09-26
• Last updated: 2020-03-10

Locations

1 site across 1 country: Canada