Use of Stimulan absorbable calcium sulphate beads in revision lower limb arthroplasty: Safety profile and complication rates

R Kallala, W Edwin Harris, M Ibrahim, M Dipane, E McPherson, R Kallala, W Edwin Harris, M Ibrahim, M Dipane, E McPherson

Abstract

Aims: Calcium sulphate has traditionally been used as a filler of dead space arising during surgery. Various complications have been described following the use of Stimulan bio-absorbable calcium sulphate beads. This study is a prospective observational study to assess the safety profile of these beads when used in revision arthroplasty, comparing the complication rates with those reported in the literature.

Methods: A total of 755 patients who underwent 456 revision total knee arthroplasties (TKA) and 299 revision total hip arthroplasties (THA), with a mean follow-up of 35 months (0 to 78) were included in the study.

Results: A total of 32 patients (4.2%) had wound drainage, and this was higher with higher bead volumes and in McPherson grade C patients. There was also a significantly higher bead volume in the 41 patients who developed hypercalcaemia, two of which were symptomatic (p < 0.0001). A total of 13 patients (1.7%) had heterotopic ossification (HO). There was no statistically significant relationship between the development of HO and bead volume (p > 0.05).

Conclusion: The strength of this study lies in the large number of patients and the detailed data collection, making it the most comprehensive report available in the literature on the use of calcium sulphate-based bone substitutes.Cite this article: R. Kallala, W. Edwin Harris, M. Ibrahim, M. Dipane, E. McPherson. Use of Stimulan absorbable calcium sulphate beads in revision lower limb arthroplasty: Safety profile and complication rates. Bone Joint Res 2018;7:570-579. DOI: 10.1302/2046-3758.710.BJR-2017-0319.R1.

Keywords: Biomaterials; Calcium Sulphate; Synthetic bone substitutes.

Conflict of interest statement

ICMJE COI Statement: None declared

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/6215242/bin/bonejointres-07-570-g001.jpg
Graphs showing a) how bead volume changes for different combinations of complication (ComPresent); b) how the percentage with complications changes with patient grade; and c) how percentage with complications changes with body location. In graphs b) and c), total sample sizes are indicated at the bottom of the bars.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/6215242/bin/bonejointres-07-570-g002.jpg
Graphs showing the subset of patients with a complication: a) bead volume changes for different types of complication; b) bead volume changes with patient grade and c) the percentage with complications changes with body location.
Fig. 3
Fig. 3
Photograph showing wound closure of deep layer using interrupted absorbable sutures.

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