Yang 2016

Methods	Design: single‐centre, parallel‐group, two‐arm randomised controlled trial Setting: Shanghai, China Timing: January 2009 – December 2011 Interventions: high‐viscosity cement vertebroplasty versus conservative treatment Sample size: sample of 48 participants per group would be required for 90% power to show at least a two‐unit (on a 0 to 10 scale) advantage of vertebroplasty over conservative treatment in respect to pain with a SD of 3.0, based on a two‐sided type 1 error of 5% Analysis: not reported
Participants	Number of participants 158 patients enrolled 23 patients excluded (18 declined to participate, 5 had other significant health problems) 135 randomly assigned (66 to vertebroplasty, 69 to conservative treatment) 5 excluded for metastases after randomisation (2 for vertebroplasty, 3 for conservative treatment) therefore 64 received vertebroplasty and 66 received conservative care Data for 107 (56/64 (87.5%) for vertebroplasty, 51/66 (77.3%) for conservative treatment) available at 12‐month assessment Inclusion criteria Vertebral compression fracture after acute minor or mild trauma Back pain 5 or more on a 0 to 10 cm VAS Low signal on T1‐weighted and high signal on T2‐weighted in MRI Level of fracture of T5 or lower Independent living without use of wheelchair prior to trauma Decreased bone mineral density (BMD) (T score less than or equal to ‐1) Exclusion criteria Chronic back pain prior to trauma Suspected underlying malignant disease Spine infection retropulsion of bony fragments Spinal cord compression syndrome Concomitant hip fracture Severe cardiopulmonary comorbidity Major coagulopathy Baseline characteristics Vertebroplasty group Mean (SD) age: 77.1 (6.0) years; 64.3% female: 35.7% male Mean (SD) bone density T score: ‐3.3 (0.6) Mean (SD) VAS score: 7.5 (1.1) Mean (SD) ODI score: 80.2 (9.9) Mean (SD) QUALEFFO: 78.1 (8.1) Usual care group Mean (SD) age: 76.2 (5.6) years; 64.7% female: 35.3% male Mean (SD) bone density T score: ‐3.2 (0.7) Mean (SD) VAS score: 7.7 (1.1) Mean (SD) ODI score: 81.5 (9.7) Mean (SD) QUALEFFO: 77.5 (8.6)
Interventions	Vertebroplasty All vertebroplasties were performed by two experienced surgeons. The patient was placed in prone position on the operating table. After local infiltration anaesthesia, a bone puncture needle was placed transpedicularly in the fractured vertebral body under a C‐arm fluoroscopic monitoring. Then, polymethylmethacrylate (PMMA) was carefully injected into the fractured vertebra with the fluoroscopic control. Injection ceased when cement reached the cortical edge of the vertebral body or leaked into the extraosseous structures or veins. If the cement did not reach the midline on the anterior‐posterior fluoroscopic film, another side of injection was performed. In patients who had more than one fracture, all the fractured bodies were treated in a single procedure. After the treatment, a CT scan of the treated vertebral bodies was completed to identify cement distribution and leakage. Usual care Patients were confined to horizontal bed rest for the initial 2 weeks after diagnosis. Then, they were encouraged to stand up and walk with brace and assistance. The bed rest time was extended if the back pain worsened when they stood up and walked. For pain medication, nonsteroidal anti‐inflammatory drugs (NSAIDs) were prescribed for every patient. Additional analgesics, such as tramadol and morphine, would be added in case NSAIDs were not effective. Two weeks after diagnosis, physical therapy was started. Follow‐up care All patients in both groups were prescribed treatment for osteoporosis including bisphosphonates, calcium supplementation, and vitamin D.
Outcomes	Outcomes were measured at 1 day, 1 week, 1, 3 and 6 months and 1 year. Primary outcome VAS mean pain score (0 to 10 cm) at one year Secondary outcomes Oswestry Disability Index (ODI) Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Patient satisfaction surveys (very satisfied, satisfied or not satisfied. Satisfaction rate reported as proportion very satisfied or satisfied) Incidence of new vertebral fractures by anterior‐posterior and lateral spine radiograph and MRI for confirmation if confirmation was required (1, 3, 6 months and 1 year) Outcomes included in this review Mean pain Oswestry Disability Index (ODI) Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Incidence of new vertebral fractures
Source of funding	No commercial entity paid for any materials used in the study. Costs of the vertebroplasty procedure, medication and physical therapy were covered by insurance.
Notes	Trial registration: not found. Not reported how many participants contributed data at 1 week, 1 month, 3 month and 6 month so we used number of participants for 12 months for all time points. Cement leakage was seen in 22 out of the 65 treated vertebral bodies.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Every patient was given a serial number according to the consecutive sequence of recruitment, and randomly assigned to PVP or conservative treatment group using computer‐generated randomised codes, according to the serial number.
Allocation concealment (selection bias)	Unclear risk	No information was provided about whether or not treatment allocation was concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and investigators were aware of treatment allocation.
Blinding of outcome assessment (detection bias) Self‐reported outcomes (e.g., pain, disability)	High risk	Participants assessed their pain and function and were not blinded.
Blinding of outcome assessment (detection bias) Objective outcomes (e.g., radiographic outcomes)	High risk	It is not stated who assessed the imaging outcomes. It is unlikely that they were blinded to treatment assignment as vertebroplasty cement is opaque and will be detected on imaging.
Incomplete outcome data (attrition bias) All outcomes	High risk	A greater number of participants completed one‐year follow‐up in the vertebroplasty group (8/64 missing, 13%) compared with 15/66 missing (23%) in the conservative treatment group. 8 (12.1%) participants in the conservative treatment group received vertebroplasty, and 2 (3%) had open surgery.
Selective reporting (reporting bias)	Unclear risk	No trial registration or published protocol found.
Other bias	Low risk	No other biases apparent.

BMD: bone mineral density CI: confidence interval CT: computed tomography IU: international unit IV: intravenous MD: mean difference MMSE: Mini‐Mental Status Examination MRI: magnetic resonance imaging NRS: numerical rating scale NSAID: non‐steroidal anti‐inflammatory drugs ODI: Oswestry Disability Index PMMA: polymethyl methacrylate QUALY:quality‐adjusted life year RCT: randomised controlled trial RMDQ: Roland‐Morris Disability Questionnaire SD: standard deviation SE: standard error SF‐36: Short form 36 VAS: visual analogue scale VCF: vertebral compression fracture