Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 12-months is indicated.

Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

The Oswestry Disability Index (ODI) Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 24-months is indicated.

Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Anterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Middle Vertebral Body Height' represents number of subjects with radiographic data available for analysis.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Posterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.

The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Kyphosis Angle' represents number of subjects with radiographic data available for analysis.

The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body.

Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Local Cobb Angle' represents number of subjects with radiographic data available for analysis.

Change in global sagittal balance as measured by sagittal vertical axis.

Due to the early termination of the study and having few sites able to image using 3-foot lateral films, sponsor will not carry out the analysis of global sagittal balance in the clinic report.

Health care utilization assessments conducted by monthly phone call to participating patients.

Due to the early termination of the study, sponsor will not carry out the analysis of secondary healthcare utilization endpoints.