SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Distal migration of the charnley femoral stem [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]
- Rotational movements of the charnley femoral stem [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2002|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Device: Bone cement 1
Bone cement SmartSet® HV
Other Name: SmartSet HV
|Active Comparator: 2||
Device: Bone cement 2
Bone cement Palacos R
Other Name: Palacos R
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.