The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain.

The best score is 0 (no disability) and worst is 24 (maximum disability)

The analyses of change from Baseline included only patients in the modified Intent-to-Treat (mITT) population who provided evaluable data at both Baseline and at 1 month after receipt of the initially assigned study treatment.

Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

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

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:

absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:

absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:

absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:

absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.

The study treatment-related AEs were defined as follows:

1. Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
2. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
3. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
4. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.

All of the randomized subjects were included in safety population analysis.

The study treatment-related AEs were defined as follows:

1. Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
2. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
3. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
4. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.

All of randomized subjects were included in safety population analysis.

Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.

Based on patients with at least 7 analyzable vertebrae.

The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.