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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837850
|Principal Investigator:||Otto S. Husby, PhD||St.Olavs hospital HF|