Table 1 Overview on comparative clinical trials (CT) of kyphoplasty
Author | Year | Design | Level of evidence* | Control Group | Control n (levels) | Kyphoplasty n (levels) | Follow-up | Outcome | Cement leakage |
|---|---|---|---|---|---|---|---|---|---|
Weisskopf et al. [56] | 2003 | Retrospective CT | IIb | non-surgical | 20 (35) | 22 (37) | 10 days | Improvement in VAS (p < 0.001) Reduced days in hospital (p < 0.01) | 5 cement leakages in kyphoplasty |
Fourney et al. [57] | 2003 | Retrrospective CT | IIb | vertebroplasty | 34 (65) | 15 (32) | 4,5 months | No significant differences in VAS and ODI Improvement of kyphosis with kyphoplasty (p < 0.01) | 0 cement leakages in kyphoplasty 6 cement leakages in vertebroplasty |
Komp et al. [58] | 2004 | Prospective CT | IIa | non-surgical | 19(19) | 21(21) | 6 months | Improvement of VAS and ODI (p < 0.01) | 0 cement leakages in kyphoplasty |
Kasperk et al [59] | 2005 | Prospective CT | IIa | non-surgical | 20 (33) | 40 (72) | 12 months | Improvement of VAS (p < 0.01) Improve of kyphosis (p < 0.001). | 7 cement leakages in kyphoplasty |
Grohs et al. [60] | 2005 | Prospective CT | IIa | vertebroplasty | 23 (29) | 28 (35) | 24 months | No significant difference in ODI Improvement of VAS with kyphoplasty (p < 0.05) No significant improve of kyphosis | 8 cement leakages in kyphoplasty 8 cement leakages in vertebroplasty |
Masala et al. [61] | 2005 | Retrospective CT | IIb | vertebroplasty | 26 (33) | 7 (7) | 6 months | No significant difference in VAS. | 0 cement leakage in kyphoplasty 11 cement leakages in vertebroplasty |
Pflugmacher et al [62] | 2005 | Prospective CT | IIa | vertebroplasty | 20 (32) | 22 (35) | 12 months | No significant difference in VAS and ODI Improvement of kyphosis with kyphoplasty (p < 0.05) | 5 cement leakages in kyphoplasty 6 cement leakages in vertebroplasty |
De Negri et al. [63] | 2007 | Prospective CT | IIa | vertebroplasty | 10 (18) | 11 (15) | 6 months | No significant difference in VAS and ODI | 0 cement leakages in kyphoplasty 1 cement leakage in vertebroplasty |
Frankel et al. [64] | 2007 | Retrospective CT | IIb | vertebroplasty | 19 (26) | 17 (20) | 6 months | No significant difference in VAS Higher rate of adjacent fractures with kyphoplasty (p < 0.05) | 3 cement leakages in kyphoplasty 2 cement leakages in vertebroplasty |
Müller et al [11] | 2007 | Randomized CT | Ib | non-surgical | 149 | 151 | 3 months | Improvement in SF-36 (p < 0.01) and VAS (p < 0.01) with kyphoplasty | Not reported |