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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00837850
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : August 26, 2011
DePuy International
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Arthritis Device: Bone cement 1 Device: Bone cement 2 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2002
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Distal migration of the charnley femoral stem [ Time Frame: 2010 ]

Secondary Outcome Measures :
  1. Rotational movements of the charnley femoral stem [ Time Frame: 2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00837850

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

Publications of Results:
Responsible Party: Norwegian University of Science and Technology Identifier: NCT00837850     History of Changes
Other Study ID Numbers: 094-02
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

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
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs