Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.

The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.

The 24 months follow-up visit did not have data collected and are not reported.

The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).

EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit.

The 24 months follow-up visit did not have data collected and are not reported.

Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).

Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).

The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.

The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.

The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.

For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment

21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.

When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.

Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other.

One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.

The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.

The following were considered as signs of instrumentation instability:

• Screw pullout
• Screw loosening
• Screw toggle

The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.

The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.

Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.

Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.

The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:

• Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL).
• Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)

Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.

Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.

The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:

• Coronal alignment : Distance between C7 plumb line and the central sacral vertical line
• Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)

Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.

Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.

The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray:

- Coronal Curve Type

Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as:

• Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower)
• Curve type T: patients with a thoracic major curve of >30˚ (apical level of T9 or higher)
• Curve type D: patients with a double major curve, with each curve >30˚.
• Curve type N: patients with no coronal curve >30˚.

Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).

Total of all reporting groups

Race and Ethnicity were not collected from any participant.

DXA scan of the Hip. A T-score within 1 SD (+1 or -1) of the young adult mean indicates normal bone density.

A T-score of 1 to 2.5 SD below the young adult mean (-1 to -2.5 SD) indicates low bone mass.

A T-score of 2.5 SD or more below the young adult mean (more than -2.5 SD) indicates the presence of osteoporosis.

For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery.

Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.

ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.

The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.

The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit.

The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point.

Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.

The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.

The 24 months follow-up visit did not have data collected and are not reported.

The results are summarized for 21 subjects who were assessed at Baseline,19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.

The 24 months follow-up visit did not have data collected and are not reported.

The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).

EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit.

The 24 months follow-up visit did not have data collected and are not reported.

The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit.

The 24 months follow-up visit did not have data collected and are not reported. The reported EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.

Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).

Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).

21 subjects were assessed at Baseline,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Due to the premature termination of the study, the number of subjects who completed the 12 months follow-up visit was very low (N=2/21, 9.5%).

The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.

21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.

The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.

21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.

The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.

For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment

21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.

21 subjects were assessed at surgery,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Adverse events up to 12 month follow-up visits are reported in the Outcome Measure Data Table.

When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.

Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other.

One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.

21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.

The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.

The following were considered as signs of instrumentation instability:

• Screw pullout
• Screw loosening
• Screw toggle

2 subjects completed the 12 month follow-up visit.

The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.

The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.

2 subjects who completed the 12 month follow-up visit were analyzed for fusion assessment with radiographic images.

Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.

Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.

The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:

• Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL).
• Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)

1 subject who completed the 12 month follow-up visit was analyzed.

Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.

Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.

The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:

• Coronal alignment : Distance between C7 plumb line and the central sacral vertical line
• Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)

1 subject who completed the 12 month follow-up visit was analyzed.

Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.

Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.

The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray:

- Coronal Curve Type

Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as:

• Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower)
• Curve type T: patients with a thoracic major curve of >30˚ (apical level of T9 or higher)
• Curve type D: patients with a double major curve, with each curve >30˚.
• Curve type N: patients with no coronal curve >30˚.

1 subject who completed the 12 month follow-up visit was analyzed.

Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).

To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.

The null hypothesis was H0: μ_ODI ≤ 0, and the alternative hypothesis was Ha: μ_ODI > 0 where μ_ODI is the mean improvement of ODI score at 3 months from baseline.

A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.

The normality of the data distribution was assessed with the Shapiro-Wilk test.

To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.

The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS > 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline.

Back Pain

A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.

The normality of the data distribution was assessed with the Shapiro-Wilk test.

To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.

The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS > 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline.

Leg Pain

A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.

The normality of the data distribution was assessed with the Shapiro-Wilk test.

To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.

The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS > 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline.

Leg Pain

A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.

The normality of the data distribution was assessed with the Shapiro-Wilk test.

To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.

The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L > 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.

Health State Score

A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.

The normality of the data distribution was assessed with the Shapiro-Wilk test.

To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.

The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L > 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.

Index score

A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.

The normality of the data distribution was assessed with the Shapiro-Wilk test.

To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.

The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L > 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.

Index score

A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.

The normality of the data distribution was assessed with the Shapiro-Wilk test.