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

Norwegian University of Science and Technology

Status

Completed

Conditions

Arthritis

Treatments

Device: Bone cement 2

Device: Bone cement 1

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00837850

094-02

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

18 to 78 years old

Volunteers

No Healthy Volunteers

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.