Leali 2016.

Methods	Design: multicentre (four centres) two‐arm randomised controlled trial Setting: Italy, France, Switzerland Timing: not reported Interventions: percutaneous vertebroplasty or usual care Sample size: sample size calculation not reported Analysis: not explicitly reported
Participants	Number of participants Number screened for eligibility not reported 400 women were reported to have been randomised (200 in percutaneous vertebroplasty, and 200 in conservative treatment equally divided between 4 hospitals, each of which treated 50 with vertebroplasty and 50 with conservative care) Data for 385 (185 (93%) for vertebroplasty and 200 (100%) for usual care) available at follow‐up Inclusion criteria Bone marrow oedema of the affected by VCF visible on MRI of the spine VCF height of the visible loss of vertebral body in radiography Acute pain from severe spinal fracture Evidence of osteoporosis in bone densitometry Evidence of an acute fracture in imaging Exclusion criteria Pathological fracture due to myeloma/metastasis Retropulsion mass of bone fragments in the spinal canal Unstable cardiopulmonary conditions Coagulopathy Incurable, systemic infection in progress Local infection spine (osteomyelitis, spondylodisciitis) Radicular syndrome or spinal cord compression Baseline characteristics: characteristics were reportedly similar but as data were reported sparsely and not reported for both groups, this could not be verified Overall: age range: 56 to 82 years Vertebroplasty group: mean baseline pain score 0 to 10 VAS: 4.8, no measure of variance reported mean baseline ODI score: 53.6, no measure of variance reported Usual care: not reported
Interventions	Vertebroplasty Vertebroplasty was performed using transpedicular approach under local anaesthesia with mepivacaine 2% and naropin 10%. A mean volume of 4 ml of PMMA was injected into each fractured vertebral body with supervision of fluoroscopy. All the patients were subjected to analgesia after surgery, according to individual needs. According to increasing analgesic power, the patients were treated with acetaminophen, non‐steroidal drugs (NSAIDs), or derivatives of morphine. Usual care Conservative care consisting of pain medication, osteoporosis medication, physiotherapy or bracing.
Outcomes	Outcomes were evaluated at 24 and 48 hours, 1 month later, 3 months, and 6 months Study outcomes VAS pain score (0 ‐ no pain to 5 ‐ maximum pain) during walking, sitting and rising from a chair, bathing, dressing, and at rest; total score is the sum of all five scores (on a scale of 0 to 25). Oswestry Disability Index (ODI), 0 to 100 scale (0 is no disability), measured at baseline and 6 months only Proportion of participants with adverse events Proportion of withdrawals Proportion with incident clinical fractures Death Outcomes included in this review Adverse events Incident clinical fractures
Source of funding	Not reported
Notes	No record of trial registration identified. Pain and disability could not be included in analyses: the trialists did not report summary statistics for each group. The trialists report that pain and disability were improved from baseline with vertebroplasty but not with usual care. Between‐group analyses were not reported, except to say that clinical results were 'similar in both groups' at 6 weeks and 3 to 6 months. Adverse events: vertebroplasty: N=2, fracture of a transverse process, bleeding of psoas muscles; incident symptomatic vertebral fractures within 6 weeks (n = 3). Usual care: no incident fractures reported. It was reported that 1 participant in the vertebroplasty group and 3 in the usual care group died 'after 6 months from their fracture'. Withdrawals: n = 15 from vertebroplasty (7 for 'technical reasons', 8 could not maintain the prone position); none reported for usual care.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Process of randomisation not described.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants and personnel unlikely due to the nature of the interventions.
Blinding of outcome assessment (detection bias) Self‐reported outcomes (e.g., pain, disability)	High risk	As participants were unblinded, there is a risk of bias in the measurement of pain and function, and adverse events.
Blinding of outcome assessment (detection bias) Objective outcomes (e.g., radiographic outcomes)	Unclear risk	Blinding of outcome assessors not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information on withdrawals or loss to follow‐up given.
Selective reporting (reporting bias)	High risk	Pain and function could not be extracted as summary data for each treatment group were not reported. No trial registration and no published protocol.
Other bias	Low risk	None apparent.