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Multicenter Study
. 2012 May;21 Suppl 1(Suppl 1):S112-8.
doi: 10.1007/s00586-012-2228-9. Epub 2012 Mar 21.

Effectiveness of a bone substitute (CERAMENT™) as an alternative to PMMA in percutaneous vertebroplasty: 1-year follow-up on clinical outcome

Affiliations
Multicenter Study

Effectiveness of a bone substitute (CERAMENT™) as an alternative to PMMA in percutaneous vertebroplasty: 1-year follow-up on clinical outcome

Stefano Marcia et al. Eur Spine J. 2012 May.

Abstract

Purpose: The aim of the study was to evaluate the efficacy of an injectable and partly absorbable calcium bone cement (CERAMENT™, Bone Support, Sweden) in the treatment of osteoporotic or traumatic vertebral fractures by percutaneous vertebroplasty.

Methods: From March 2009 to October 2010 an open, prospective study in two centres was performed. 33 patients with symptomatic vertebral fractures were enrolled. Patients were included based on evaluation by X-ray, CT, and MRI. Clinical evaluation by Visual Analogue Scale (VAS, 0-10) and Oswestry Disability index test (ODI, 0-100 %) was performed before the operation as well as 1, 6 and 12 months after the procedure. Radiology assessment post-procedure was carried out by X-ray, CT, and MRI at 1, 6 and 12 months post-op. Intake of analgesic medications pre- and post-procedure was monitored.

Results: 66 vertebral bodies underwent percutaneous vertebroplasty. VAS score demonstrated a significant decrease from 8.61 (SD 19.8) pre-operatively to 2.48 (SD 2.36) at 1 month. The score was 2.76 (SD 2.68) at 6 months and 1.36 (SD 1.33) at the latest follow up. ODI score dropped significantly from 58.86 pre-op to 26.94 at 6 months and further down to 7.61 at 12 months. No re-fractures or adjacent level fractures were reported.

Conclusion: Data show that CERAMENT can be a substitute of PMMA in the treatment of osteoporotic and traumatic vertebral fractures, especially in young patients.

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Figures

Fig. 1
Fig. 1
Anteroposterior and latero-lateral intraprocedural fluoroscopic view
Fig. 2
Fig. 2
Anteroposterior and latero-lateral intraprocedural fluoroscopic view shows the good opacity of the bone cement
Fig. 3
Fig. 3
CTms check after procedure
Fig. 4
Fig. 4
CTms check 1 month after procedure: poor visualization of the bone cement into vertebral bodies
Fig. 5
Fig. 5
X-ray film check 1 month after procedure: poor visualization of the bone cement into vertebral bodies
Fig. 6
Fig. 6
MRI check 1 month after procedure: reduction of hyperintensity in T2Fat Sat sequences
Fig. 7
Fig. 7
X-ray film check 12 months after procedure: no visualization of the bone cement into vertebral bodies
Fig. 8
Fig. 8
CTms check 12 months after procedure: the bone cement has been progressively included into the vertebral bodies
Fig. 9
Fig. 9
MRI check 12 months after procedure: further reduction of hyperintensity in T2Fat Sat sequences
Fig. 10
Fig. 10
Changes in terms of analgesic drug use
Fig. 11
Fig. 11
VAS score shows a decrease over the 12-month follow-up
Fig. 12
Fig. 12
ODI score shows a significant improvement over the 12-month follow-up

References

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