Introduction The objective of this prospective, randomized study was to test the feasibility and the clinical outcome of the different forms of treatment.
Material and methods In 40 patients with a total of 57 sacral fractures, cement augmentation was performed with CT-guidance by means of balloon sacroplasty (BSP) or radiofrequency sacroplasty (RFS). For BSP, the balloon catheter was inflated and deflated in the fracture zone, and the hollow space created was then filled with PMMA cement. For RFS, a flexible osteotome was initially used to extend the spongious space in the fracture zone. The highly viscous PMMA cement, activated by radiofrequency, was then inserted into the prepared fracture zone. Pain intensity was determined on a visual analogue scale before the intervention, on the second day, and 6, 12 and 18 months after the intervention. The results were tested for significance by means of paired Wilcoxon rank-sum tests and Mann-Whitney U tests.
Results BSP and RFS were technically feasible in all patients. An average of 6.3 ml cement per fracture were inserted in the BSP group and an average of 6.1 ml per fracture in the RFS group. Leakage could be ruled out for both procedures. The mean pain score on the VAS before the intervention was 8.6 ± 0.55 in the BSP group and 8.8 ± 0.58 in the RFS group. On the second postoperative day, a significant pain reduction was seen (p < 0.001), with an average value of 2.5 (BSP ± 0.28, RFS ± 0.38) for both groups. After 6 (12; 18) months, these values were stable for the BSP group at 2.3 ± 0.27 (2.3 ± 0.24; 2.0 ± 0.34) and for the RFS group at 2.4 ± 0.34 (2.2 ± 0.26; 2.0 ± 0.31). With regard to pain, exceedance probability values of p = 0.86 (6 months) and p = 1 (18 months) were seen, so that neither treatment method leads to differences in results.
Conclusion BSP and RFS are interventional, minimally invasive procedures that enable reliable cement augmentation and achieve equally good clinical outcomes in the medium term.
Disclosures R. Andresen: None. S. Radmer: None. J. Andresen: None. H. Schober: None.
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