Dataset Information

The effect of adding tobramycin to Simplex P cement on femoral stem micromotion as measured by radiostereometric analysis: a 2-year randomized controlled trial.

ABSTRACT:

Background

Previous in vitro research on addition of antibiotics to bone cement has found no statistically significant deterioration in mechanical properties. However, no clinical studies have compared the performance of tobramycin-laden bone cement with that of standard bone cement (Simplex P).

Patients and methods

23 patients (25 hips) were randomized to receive an Exeter (Stryker Orthopaedics) femoral stem cemented with either Simplex P (standard) or Simplex T (tobramycin-laden) cement. There were 2 years of follow-up, with scheduled radiostereometric (RSA) examinations.

Results

All stems migrated distally and showed some degree of retroversion. No clinically significant differences in stem subsidence or retroversion were found between the Simplex T and Simplex P cement groups after 2 years. Overall subsidence was less than in previous studies, probably due to a postponed initial post-surgical examination. Rates of subsidence in both cement groups were consistent with those from previous studies of Exeter stems.

Interpretation

Subsidence of the femoral stem after 2 years was similar in the Simplex T (tobramycin-laden) and Simplex P (standard) groups.

SUBMITTER: Bohm E

PROVIDER: S-EPMC3339523 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Publications

The effect of adding tobramycin to Simplex P cement on femoral stem micromotion as measured by radiostereometric analysis: a 2-year randomized controlled trial.

Bohm Eric E Petrak Martin M Gascoyne Trevor T Turgeon Thomas T

Acta orthopaedica 20120117 2

<h4>Background</h4>Previous in vitro research on addition of antibiotics to bone cement has found no statistically significant deterioration in mechanical properties. However, no clinical studies have compared the performance of tobramycin-laden bone cement with that of standard bone cement (Simplex P).<h4>Patients and methods</h4>23 patients (25 hips) were randomized to receive an Exeter (Stryker Orthopaedics) femoral stem cemented with either Simplex P (standard) or Simplex T (tobramycin-laden ...[more]

PMID: 22248163

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Project description:In clinical trials of THA, model-based radiostereometric analysis (RSA) techniques may be less precise than conventional marker-based RSA for measurement of femoral stem rotation. We verified the accuracy and clinical precision of RSA based on computer-aided design models of a cementless tapered wedge femoral stem.We asked: (1) Is the accuracy of model-based RSA comparable to that of marker-based RSA? (2) What is the clinical precision of model-based RSA?Model-based RSA was performed using combined three-dimensional computer-aided design models of the stem and head provided by the implant manufacturer. The accuracy of model-based RSA was compared with that of marker-based RSA in a phantom model using micromanipulators for controlled translation in three axes (x, y, z) and rotation around the y axis. The clinical precision of model-based RSA was evaluated by double examinations of patients who had arthroplasties (n = 24) in an ongoing trial. The clinical precision was defined as being at an acceptable level if the number of patients needed for a randomized trial would not differ from a trial done with conventional marker-based RSA (15-25 patients per group).The accuracy of model-based RSA was 0.03 mm for subsidence (translation along the y axis) (95% CI for the difference between RSA measurements and actual displacement measured with micrometers, -0.03-0.00) and 0.39° for rotation around the y axis (95% CI, -0.41 to -0.06). The accuracy of marker-based RSA was 0.06 mm for subsidence (95% CI, -0.04-0.01; p = 0.728 compared with model-based RSA) and 0.18° for the y axis rotation (95% CI, -0.23 to -0.07; p = 0.358). The clinical precision of model-based RSA was 0.14 mm for subsidence (95% CI for the difference between double examinations, -0.02-0.04) and 0.79° for the y axis rotation (95% CI, -0.16-0.18).The accuracy of model-based RSA for measurement of the y axis rotation was not quite as high as that of marker-based RSA, but its clinical precision is at an acceptable level.Model-based RSA may be suitable for clinical trials of cementless tapered wedge femoral stem designs.

Dataset Information

The effect of adding tobramycin to Simplex P cement on femoral stem micromotion as measured by radiostereometric analysis: a 2-year randomized controlled trial.

Background

Patients and methods

Results

Interpretation

Publications

The effect of adding tobramycin to Simplex P cement on femoral stem micromotion as measured by radiostereometric analysis: a 2-year randomized controlled trial.

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