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Table 2 Overview on comparative clinical trials of kyphoplasty

From: Kyphoplasty in osteoporotic vertebral compression fractures - Guidelines and technical considerations

Author

Year

Design

Level of evidence

Control Group

Control n (levels)

Kyphoplasty n (levels)

Follow-up

Outcome

Weisskopf et al. [54]

2003

Retrospective

IIIb

non-surgical

20 (35)

22 (37)

10 days

Improvement in VAS (p < 0.001) Reduced days in hospital (p < 0.01)

Fourney et al. [55]

2003

Retrrospective

IIIb

vertebroplasty

34 (65)

15 (32)

4,5 months

No significant differences in VAS and ODI Improvement of kyphosis with kyphoplasty (p < 0.01)

Komp et al. [56]

2004

Prospective

IIb

non-surgical

19(19)

21(21)

6 months

Improvement of VAS and ODI with kyophoplasty (p < 0.01)

Kasperk et al [57]

2005

Prospective

IIb

non-surgical

20 (33)

40 (72)

12 months

Improvement of VAS (p < 0.01) and improvement of kyphosis (p < 0.001) with kyphoplasty

Grohs et al. [58]

2005

Prospective

IIb

vertebroplasty

23 (29)

28 (35)

24 months

No significant difference in ODI, but improvement of VAS with kyphoplasty (p < 0.05). No significant improvement of kyphosis

Masala et al. [59]

2005

Retrospective

IIIb

vertebroplasty

26 (33)

7 (7)

6 months

No significant difference in VAS.

Pflugmacher et al [30]

2005

Prospective

IIb

vertebroplasty

20 (32)

22 (35)

12 months

No significant difference in VAS and ODI. Improvement of kyphosis with kyphoplasty (p < 0.05)

De Negri et al. [60]

2007

Prospective

IIb

vertebroplasty

10 (18)

11 (15)

6 months

No significant difference in VAS and ODI.

Zhou et al. [61]

2008

Prospective

IIIb

vertebroplasty

42

56

12 months

No significant differences in VAS, operation time and blood loss. Improved vertebral height restoration with kyphoplasty (p < 0.01).

Wardlaw et al. [13]

2009

Randomised

Ib

non-surgical

149

151

12 months

Significant improvement in EQ-5D (p < 0.05), RMDQ (p < 0.001) VAS (p < 0.0001).

Schmelzer-Schmied et al. [51]

2009

Prospective

IIb

non-surgical

20

20

12 months

Significant greater improvement of VAS (p < 0.05) with kyphoplasty, which was lost after 3 months, and vertebral height preservation after 12 months (p < 0.01)

Schofer et al. [62]

2009

Prospective

IIIb

vertebroplasty

30

30

13 months

No significant differences in VAS and SF-36. Greater improvement of kyphotic angle with kyphoplasty (p < 0.001)

Li X et al [63]

2011

Prospective

IIIb

vertebroplasty

40

45

12 months

No significant differences in VAS and ODI. Significantly greater improvement of kyphotic angle with kyphoplasty (p < 0.01)

  1. VAS: Visual Analogous Scale, ODI: Oswestry Disability Index, EQ-5D: EuroQoL, RMDQ: Roland Morris Disability Questionnaire, SF-36: Short Form Health Survey.