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Table 4 Morbidity and mortality during mean follow-up of the studies

From: Percutaneous cement augmentation in the treatment of osteoporotic vertebral fractures (OVFs) in the elderly: a systematic review

Study Comparators N total Total new VFs Procedure/fracture-related mortality Morbidity Morbidity definition Cement extravasation
RCTs PV versus placebo/sham
1. Firanescu et al. [28] PV versus placebo 180 31 versus 28 NR 2 (n = 2) versus 0 1 respiratory insufficiency the day after the procedure, related to underlying pulmonary disease, 1 vasovagal reaction during the procedure that spontaneously resolved 105 (91%)
2. Clark et al. [12]a PV versus Placebo 120 3 versus 7 2 (n = 2) versus 2 (n = 2) 1 respiratory arrest post-sedation, 1 supracondylar humerus fracture in a paretic arm during transfer versus 2 spinal cord compressions due to interval collapse and retropulsion of the fracture Asymptomatic
21 (34%)
3. Kroon et al. [13] PV versus Placebo 78 12 versus 11 NR NR NR Asymptomatic
13 (39.3%)
4. Comstock et al. [15] PV versus control 131 NR NR NR NR NR
RCTs PV/PKP versus CT
1. Yang et al. [11] PV versus CT 135 5 versus 4
p = 0.992
10 (n = 9) versus 24 (n = 18)
p < 0.0001
2 urinary tract infections, 2 deep vein thrombosis, 2 depressions, 4 sleep disorders versus 2 pneumonia, 5 urinary tract infections, 4 deep vein thrombosis, 5 depressions, 8 sleep disorders Asymptomatic
22 (33.8%)
2. Chen et al. [14] PV versus CT 96 3 versus 7
p = 0.277
NR NR NR Asymptomatic
36 (52%)
3. Blasco et al. [16] PV versus CT 125 29 versus 8 NR NR Asymptomatic
23 (49%)
4. Boonen et al. [17]b PKP versus CT 300 56 versus 45
p = 0.68
n = 134, SAE 74 versus n = 134, SAE 73 2 SAE related to kyphoplasty; one recollapse of a treated vertebrae with anterior migration of cement, another patients with spondylodiscitis NR
5. Farrokhi et al. [18]b PV versus CT 82 1 versus 6
p < 0.01
n = 1 versus 0 No significant complications except one complication related to cement extravasation in the vertebroplasty group 14 (14%), in 1 patient epidural cement leak caused severe right lower extremity pain and weakness
6. Klazen et al. [19] PV versus CT 202 18 versus 30
p = 0.44
n = 2 versus 0 1 urinary tract infection, 1 asymptomatic cement deposition in a segmental pulmonary artery in the vertebroplasty group Asymptomatic cement leakage frequency NR
7. Rousing et al. [20] PV versus CT 50 4 versus 3 n = 0 No significant complications Asymptomatic cement leakage frequency NR
Non-RCTs
1. Andrei et al. [21] PV versus CT 66 4 versus 5 n = 0 No significant complications NR
2. Marcías-Hernández et al. [22] PV versus CT 31 1 versus 0 NR n = 1 1 radiculopathy in the vertebroplasty group NR
3. Lee et al. [23] PKP versus CT 259 5 versus 8
p > 0.05
NR n = 0 No significant complications Asymptomatic cement leakage frequency NR
4. Wang et al. [24] PVP versus CT 55 8 versus 1   n = 1 No significant complications except one complication related to asymptomatic cement migration toward the lungs 1 asymptomatic pulmonary PMMA emboli, cement leakage frequency NR
5. Nakano et al. [25] PV versus CT 60 NR NR n = 1 1 temporary respiratory insufficiency during CPC injection in the vertebroplasty group Asymptomatic
8 (26.7%)
6. Alvarez et al. [26] PV versus CT 128 36 versus 3
p < 0.01
NR n = 8 1 transitory paraparesis from a massive PMMA leakage into the canal, 5 transitory radicular neuritis, 2 rib fractures related to positioning in the vertebroplasty group 90 (59.6%), 7% symptomatic
7. Diamond et al. [27] PV versus CT 126 29 versus 11
p = 0.76
5 fracture-related deaths, 4 occuring in the CT group n = 3 2 fractured transverse processes, 1 psoas muscle hematoma in the vertebroplasty group NR
  1. NR not reported, SAE serious adverse event
  2. aResults only available and reported for the 6-month follow-up period
  3. bResults only available and reported for the 24-month follow-up period