SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty

Arthritis Clinical Trial

Official title: A Randomised Prospective Trial of SmartSet HV and Palacos R Bone Cements in Primary Total Hip Arthroplasty. A Radiostereometric Analysis of the Charnley Femoral Component.

Status Completed

Clinical Trial Summary

A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

Clinical Trial Description

The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity.

Studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

• NCT number: NCT00837850
• Study type: Interventional
• Source: Norwegian University of Science and Technology
• Status: Completed
• Phase: N/A
• Start date: October 2002
• Completion date: October 2008