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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00837850

Enrollment

Registered

2009-02-05

Start date

2002-10-31

Completion date

2008-10-31

Last updated

2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Keywords

total hip arthroplasty, Charnley stem, RSA, non-inflammatory arthritis

Brief summary

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

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.

Interventions

DEVICEBone cement 1

Bone cement SmartSet® HV

DEVICEBone cement 2

Bone cement Palacos R

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

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.

Design outcomes

Primary

Measure	Time frame
Distal migration of the charnley femoral stem	2010

Secondary

Measure	Time frame
Rotational movements of the charnley femoral stem	2010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026