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

This study has been completed.
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00837850
First received: February 4, 2009
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention
Arthritis
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.

  Eligibility

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00837850

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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov 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
RSA
non-inflammatory arthritis

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014