Skip to main content
OpenTrials
Completed

NCT Number: NCT00837850

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients in need for total hip arthroplasty

Exclusion criteria

  • patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),
  • patients on corticosteroid treatment,
  • patients who had already participated in a clinical study with an investigational product in the last 6 months.

Treatment and study plan

Bone cement 1

Device

Bone cement SmartSet® HV

Other names: SmartSet HV

Bone cement 2

Device

Bone cement Palacos R

Other names: Palacos R

Primary outcomes

  1. Distal migration of the charnley femoral stem

    Time frame: 2010

Secondary outcomes

  1. Rotational movements of the charnley femoral stem

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • DePuy International

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2003
Study completion
2008
First posted
Feb 5, 2009
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.