NCT00837850

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arthritis

Interventions

Type	Name	Description
DEVICE	Bone cement 1	Bone cement SmartSet® HV
DEVICE	Bone cement 2	Bone cement Palacos R

Timeline

• Start date: 2002-10-01
• Primary completion: 2003-10-01
• Completion: 2008-10-01
• First posted: 2009-02-05
• Last updated: 2011-08-26