2. Baseline demographic and clinical characteristics of the trial participants.
Study | Country | Treatment Groups | Mean age, yrs | Mean symptom duration | Mean (SD) baseline pain (0‐10 scale$) | Mean (SD) baseline RMDQ+ (0‐24 scale†) | Mean (SD) baseline QUALEFFO (0‐100 scale) | Procedures performed by | Mean (range) volume cement injected (mL) | Follow‐up |
Blasco 2012 | Spain | Vertebroplasty | 71.3 | 140.3 days | 7.2 (0.3) | ‐ | 65.2 (2.2) | Interventional radiologists | Not specified | 2 weeks, 2, 6, 12 months |
Usual care | 71.3 | 143.1 days | 6.3 (0.4) | ‐ | 59.2 (2.2) | |||||
Buchbinder 2009 | Australia | Vertebroplasty | 74.2 | 9 weeks^ | 7.4 (2.1) | 17.3 (2.8) | 56.9 (13.4) | Interventional radiologists | 2.8 (1.2 ‐ 5.5) | 1 week, 1, 3, 6, 12, 24 months |
Placebo | 78.9 | 9.5 weeks^ | 7.1 (2.3) | 17.3 (2.9) | 59.6 (17.1) | |||||
Clark 2016 | Australia | Vertebroplasty | 80 | 2.8 weeks | 8.1 (1.8) | 19.5 (3.5) | 65.4 (11.4) | Interventional radiologists | 7.5 (4.7 ‐ 10.3) | 3 days, 14 days, 1, 3 and 6 months |
Placebo | 81 | 2.4 weeks | 8.2 (1.5) | 19.8 (3.7) | 67.7 (11.2) | |||||
Chen 2014a | China | Vertebroplasty | 64.6 | 31 weeks | 6.5 (0.9)& | 18.6 (1.8)#& | ‐ | Orthopaedic surgeons | 3.6 (3 ‐ 6) | 1 day, 1 week, 1, 3, 6, 12 months |
Usual care and brace | 66.5 | 29.5 weeks | 6.4 (0.9)& | 16.7 (1.3)#& | ‐ | |||||
Dohm 2014 | USA and Canada | Vertebroplasty | 75.7 | ‐¤ | ˜7.6µ | ‐ | ‐ | Interventional radiologists and neuroradiologists, orthopaedic surgeons, neuroradiologists | 4.0 (3.0 to 6.0)¢ | 7 days, 1, 3, 12 and 24 months |
Balloon kyphoplasty | 75.5 | ‐¤ | ˜7.6µ | ‐ | ‐ | Not stated | 4.6 (3.4 to 6.0)¢ | |||
Endres 2012 | Germany | Vertebroplasty | 71.3 | ‐§ | 7.8 (0.9) | ‐ | ‐ | Orthopaedic surgeon | 3.1 (2 – 4) | Immediately, mean 5.8 months (range: 4 to 7) |
Balloon kyphoplasty | 63.3 | ‐§ | 9.0 (0.7) | ‐ | ‐ | Orthopaedic surgeon | 3.9 (3 – 5) | |||
Shield kyphoplasty | 67.1 | ‐§ | 8.8 (1.5) | ‐ | ‐ | Orthopaedic surgeon | 4.6 (3 – 6) | |||
Evans 2015 | USA | Vertebroplasty | 76.1 | ‐ | 7.9 (2.0) | 16.3 (7.4) | ‐ | Not reported | Not reported | 3 days, 1, 6 and 12 months |
Kyphoplasty | 75.1 | ‐ | 7.4 (1.9) | 17.3 (6.6) | ‐ | Not reported | Not reported | |||
Farrokhi 2011 | Iran | Vertebroplasty | 72 | 27 weeks | 8.4 (1.6) | ‐ | ‐ | Neurosurgeons | 3.5 (1 ‐ 5.5) | 1 week, 2, 6, 12, 24, 36 months |
Usual care | 74 | 30 weeks | 7.2 (1.7) | ‐ | ‐ | |||||
Firanescu 2018 | the Netherlands | Vertebroplasty | 74.7 | 29.2 days | 7.7 (1.4) | 18 (4.5) | 68.4 (17.1) | Interventional radiologists | 5.11 (1 ‐ 11) | 1 day, 1 week, 1, 3, 6, 12 months |
Placebo | 76.8 | 25.9 days | 7.9 (1.6) | 17.8 (4.7) | 69.7 (17.9) | |||||
Kallmes 2009 | US, UK, Australia | Vertebroplasty | 73.4 | 16 weeks | 6.9 (2.0) | 16.6 (3.8) | ‐ | Interventional radiologists | 2.8 (1 ‐ 5.5)* | 3 days, 2 weeks, 1 month |
Placebo | 73.3 | 20 weeks | 7.2 (2.0) | 17.5 (4.1) | ‐ | |||||
Klazen 2010 | the Netherlands, Belgium | Vertebroplasty | 75.2 | 29.3 days | 7.8 (1.5) | 18.6 (3.6)# | 58.7 (13.5) | Interventional radiologists | 4.1 (1 ‐ 9) | 1 day, 1 week, 1, 3, 6, 12 months |
Usual care | 75.4 | 26.8 days | 7.5 (1.6) | 17.2 (4.2)# | 54.7 (14.4) | |||||
Leali 2016 | Italy | Vertebroplasty | ‐ | ‐§ | 4.8 (‐) | 53.6 (‐) | ‐ | Not reported | 4 (‐) | 1 and 2 days, 6 weeks, 3 and 6 months |
Usual care | ‐ | ‐§ | ‐§ | ‐ | ‐ | Not reported | ||||
Liu 2010 | Taiwan | Vertebroplasty | 74.3 | 15.8 days | 7.9 (0.7) | ‐ | ‐ | Not reported | 4.9 (0.7) | 3 days, 6 months, 1, 3 and 5 years |
Balloon kyphoplasty | 72.3 | 17.0 days | 8.0 (0.8) | ‐ | ‐ | Not reported | 5.6 (0.6) | |||
Rousing 2009 | Denmark | Vertebroplasty | 80 | 8.4 days | 7.5 (2.0) | ‐ | ‐ | Orthopaedic surgeons | Not reported | 3 months |
Usual care and brace | 80 | 6.7 days | 8.8 (1.2) | ‐ | ‐ | |||||
Sun 2016 | China | Vertebroplasty | 65.4 | ‐ | 8.5 (1.1) | 70.6 (8.6)× | ‐ | Not reported | 3.4 (0.3) | 2 days, 12 months |
Kyphoplasty | 65.2 | ‐ | 8.2 (0.9) | 71.7(8.5)× | ‐ | Not reported | 4.2 (0.2) | |||
Vogl 2013 | Germany and USA | Vertebroplasty | 74 | ‐¥ | 8.5 (1.2) | ‐ | ‐ | Not reported | 4.0 (1.1) | 1 day, 3 and 12 months |
Shield kyphoplasty | 80 | ‐¥ | 8.3 (1.1) | ‐ | ‐ | Not reported | 3.8 (0.7) | |||
Voormolen 2007 | the Netherlands | Vertebroplasty | 72 | 85 days | 7.1 (5 ‐ 9)+ | 15.7 (8‐24) | 60.0 (37 to 86) | Interventional radiologists | 3.2 (1.0 ‐ 5.0) | 2 weeks |
Usual care | 74 | 76 days | 7.6 (5‐10) | 17.8 (8‐22) | 60.7 (38 to 86) | |||||
VOPE 2015 | Denmark | Vertebroplasty | 70.6 | ‐ª | 7.47 () | ‐ | ‐ | Orthopaedic surgeons | Not reported˜ | 6 hours, weekly to 3 months, 12 months |
Placebo (lidocaine injected) | 69.3 | ‐ª | 7.61 () | ‐ | ‐ | Orthopaedic surgeons | ||||
Wang 2015 | China | Vertebroplasty | 69.43 | ‐ | 8.1 (1.2) | 71.22 (10.56)× | ‐ | Not reported | 3.31 (0.77) | 1 day, 3 and 12 months |
Balloon kyphoplasty | 68.63 | ‐ | 8.0 (1.1) | 71.30 (10.22)× | ‐ | Not reported | 4.22 (1.29) | |||
Wang 2016 | China | Vertebroplasty | 63.7 | ‐ª | 7.65 (1.11) | 18.3 (1.0) | ‐ | Spine surgeon | 5.5 (3.0 ‐ 9.0) | |
Facet joint injection | 62.6 | ‐ª | 7.76 (1.06) | 18.45 (0.98) | ‐ | Spine surgeon | ||||
Yang 2016 | China | Vertebroplasty | 77.1 | Not reported | 7.5 (1.1) | 80.2 (9.9)× | 78.1 (8.1) | Not stated | 4.5 (3‐6.5) | 1 week, 3, 6 and 12 months |
Usual care | 76.2 | Not reported | 7.7 (1.1) | 81.5 (9.7)× | 77.5 (8.6) |
$1‐10 point scale used by Farrokhi 2011, 0 to 100 scale used by VOPE 2015 and we report pain with forward bending for this trial as overall pain not reported and have converted SE to SD; +RMDQ: Roland‐Morris Disability Questionnaire; †modified RMDQ (0‐23 scale) used by Buchbinder 2009, Kallmes 2009 and Firanescu 2018; ×Oswestry Disability Index (0 to 100) used by Leali 2016, Wang 2015, Yang 2016; ^ median duration of symptoms; ¤Not reported but symptom duration 6 months or less; µMean symptom duration reported graphically only; ¢Median and interquartile range;§Not reported but symptom duration 6 weeks or less; ªNot reported but symptom duration 8 weeks or less; &Data only included for the 42/46 in VP group and 43/50 in the usual care group who completed 12‐month follow‐up in groups assigned to at baseline; #Disability significantly higher in the vertebroplasty group; *from n = 20 treated at Mayo (personal communication); ¥Not reported but at least 6 weeks of conservative treatment; +Only range provided; ˜up to 2 mL.