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

This study has been completed.
DePuy International
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: February 4, 2009
Last updated: August 25, 2011
Last verified: August 2011

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

Condition Intervention
Device: Bone cement 1
Device: Bone cement 2

Study Type: Interventional
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.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Distal migration of the charnley femoral stem [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rotational movements of the charnley femoral stem [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: October 2002
Study Completion Date: October 2008
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00837850

Sponsors and Collaborators
Norwegian University of Science and Technology
DePuy International
Principal Investigator: Otto S. Husby, PhD St.Olavs hospital HF
  More Information

Responsible Party: Norwegian University of Science and Technology Identifier: NCT00837850     History of Changes
Other Study ID Numbers: 094-02
Study First Received: February 4, 2009
Last Updated: August 25, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
total hip arthroplasty
Charnley stem
non-inflammatory arthritis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs processed this record on April 15, 2014