Cancer, Spinal Fractures
Conditions
Keywords
Balloon Kyphoplasty, Cancer, Vertebral Compression Fracture, Back Pain, Spine
Brief summary
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.
Detailed description
1\. STUDY OBJECTIVES AND ENDPOINTS 1.1. Objectives The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer. 1.2. Primary Endpoint The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment. 1.3. Secondary Endpoints The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit. Safety: * Rate of study treatment-related adverse events * Change in neurological status Clinical: * Change in functional status as assessed with Karnofsky Performance Scale * Change in quality of life as assessed by the SF-36v2™ Health Survey * Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS) * Change in back-pain analgesics used * Change in ambulation status * Changes in activities of daily living * Time to treatment failure Radiographic: * Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory * Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.
Interventions
DEVICEBalloon Kyphoplasty
Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
OTHERNon Surgical Management
Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.
Sponsors
Medtronic Spine LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a fracture imaged by plain radiographs using the method of Genant 2. Pain NRS score ≥4 on a scale of 0 to 10 * When the patient is newly diagnosed with multiple myeloma, the pain assessment must not be done until after completion of at least one pulse of steroid therapy or one week after the initiation of active multiple myeloma therapy. 3. Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24 4. Patients must be at least 21 years old. 5. No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment 6. No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment 7. No major surgery to the spine planned for at least 1 month following enrollment 8. Life expectancy of ≥ 3 months 9. Patient has sufficient mental capacity to comply with the protocol requirements 10. Patient has stated availability for all study visits 11. Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.
Exclusion criteria
1. Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible. 2. Concurrent Phase I investigational anti-cancer treatment 3. Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function 4. VCF morphology deemed unsuitable for balloon kyphoplasty 5. Additional non-kyphoplasty surgical treatment is required for the index fracture 6. Patients requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible. 7. Patients with a platelet count of \< 20,000 measured at the time of hospital admission for the procedure 8. Spinal cord compression or canal compromise requiring decompression 9. Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be enrolled. 10. Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection) 11. Known allergy to bone cement or contrast medium used in the treatment of study subjects 12. MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis) 13. Positive baseline pregnancy test (for women of child-bearing potential) 14. Patients who may require allogeneic bone marrow transplantation during the course of the study. Other Reasons for Lack of Enrollment: A. Patient is afraid to have surgery B. Patient is afraid to have anesthesia C. Patient/family is not willing to participate in research D. Patient is not willing to be randomized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month | Baseline and 1 Month | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Status Assessed With the Karnofsky Performance Scale | 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). |
| Change in Back Pain | Baseline and 1 month | Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain). |
| Change in Quality of Life. | Baseline and 1 month | 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. |
| Change in Quality of Life | Baseline, 1 month, 3 months, 6 months, and 12 months | 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. |
| Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | 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. |
| Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | 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. |
| Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | 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. |
| Ambulatory Status Change From Baseline to One Month | 1 month | Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory. |
| Ambulatory Status Change | Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months | Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory. |
| Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | 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. |
| Change in Roland-Morris Disability Questionnaire Score | Baseline, 1 month, 3 months, 6 months, and 12 months | 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). |
| Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | 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. |
| Back Pain Analgesics Used | Baseline, 7 days, and 1 month | — |
| Change in Neurology Status From Baseline (Motor Strength) | 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 |
| Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | 1 month, 3 months, 6 months, and 12 months | 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 |
| Change in Neurological Status From Baseline (Sensory Examination) | 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. |
| Change in Neurological Status From Baseline (Reflex Strength) | 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 |
| Change in Neurological Status From Baseline (Limb Strength) | 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). |
| Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | 1 month | 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. |
| Rate of Study Treatment-related Adverse Events Till Study Completion | 12 months | 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. |
| Rate of Subsequent Vertebral Body Fractures | 1 month | — |
| Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Baseline, post-operation, 1 month, and 12 months | 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. |
Countries
Australia, Belgium, Canada, Germany, Hungary, Sweden, United Kingdom, United States
Participant flow
Recruitment details
Of 134 enrolled subjects, 70 were randomized to Balloon Kyphoplasty and 64 to non-surgical management (NSM). Two of the subjects who were randomized to Balloon Kyphoplasty and 3 of the subjects who were randomized to NSM were excluded from the mITT and PP Populations, because they terminated in a few days of enrolment and had no treatment.
Pre-assignment details
Crossover from the NSM group to Balloon Kyphoplasty group was permitted after completion of the 1-month evaluation.
Participants by arm
| Arm | Count |
|---|---|
| Balloon Kyphoplasty The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. | 70 |
| Non Surgical Management The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. | 64 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 12 Months | Death | 8 | 2 | 3 |
| 12 Months | Lost to Follow-up | 1 | 0 | 1 |
| 12 Months | unrelated medical problem | 0 | 0 | 1 |
| 12 Months | Withdrew | 0 | 0 | 1 |
| 1 Month | Additional surgery needed | 1 | 0 | 0 |
| 1 Month | Death | 2 | 1 | 0 |
| 1 Month | Lost to Follow-up | 0 | 2 | 0 |
| 1 Month | Non-medical problem | 0 | 2 | 0 |
| 1 Month | Withdrew | 0 | 4 | 0 |
| 3 Months | Could not comply with protocol | 1 | 0 | 0 |
| 3 Months | Death | 7 | 3 | 0 |
| 3 Months | Non-medical problem | 0 | 0 | 1 |
| 3 Months | Withdrew | 0 | 1 | 0 |
| 6 Months | Could not comply with protocol | 0 | 2 | 0 |
| 6 Months | Death | 6 | 0 | 3 |
| 6 Months | Lost to Follow-up | 2 | 0 | 0 |
| Baseline | Refused random assignment | 1 | 0 | 0 |
| Baseline | Withdrew | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | Balloon Kyphoplasty | Non Surgical Management | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 10.8 | 63.0 years STANDARD_DEVIATION 11.4 | 63.9 years STANDARD_DEVIATION 11 |
| Sex/Gender, Customized Female | 40 participants | 35 participants | 75 participants |
| Sex/Gender, Customized Male | 28 participants | 26 participants | 54 participants |
| Sex/Gender, Customized Missing | 2 participants | 3 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 70 | 11 / 64 |
| serious Total, serious adverse events | 15 / 70 | 11 / 64 |
Outcome results
Primary
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
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)
Time frame: Baseline and 1 Month
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Balloon Kyphoplasty | The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month | Baseline | 17.6 score on a scale |
| Balloon Kyphoplasty | The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month | One month | 9.1 score on a scale |
| Balloon Kyphoplasty | The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month | Change from baseline to one month | -8.3 score on a scale |
| Non Surgical Management | The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month | Baseline | 18.2 score on a scale |
| Non Surgical Management | The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month | One month | 18.0 score on a scale |
| Non Surgical Management | The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month | Change from baseline to one month | 0.1 score on a scale |
Secondary
Ambulatory Status Change
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Time frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status no change at 7 days | 79 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Assisted ambulatory at baseline | 32 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Not ambulatory at baseline | 10 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status improved at 7 days | 10 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Full ambulatory at baseline | 56 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status worsened at 7 days | 2.9 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status improved at 1 month | 16 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status no change at 1 month | 74 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status worsened at 1 month | 2.9 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status improved at 3 months | 18 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status no change at 3 months | 53 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status worsened at 3 months | 8.8 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status improved at 6 months | 10 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status no change at 6 months | 54 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status worsened at 6 months | 5.9 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status improved at 12 months | 12 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status no change at 12 months | 41 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change | Ambulatory status worsened at 12 months | 4.4 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status worsened at 12 months | 4.3 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Full ambulatory at baseline | 57 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status improved at 3 months | 4.3 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status improved at 6 months | 4.3 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Assisted ambulatory at baseline | 30 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status improved at 1 month | 0 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status worsened at 6 months | 4.3 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Not ambulatory at baseline | 13 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status no change at 3 months | 35 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status worsened at 1 month | 13 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status improved at 7 days | 0 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status improved at 12 months | 4.3 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status no change at 6 months | 26 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status no change at 7 days | 70 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status worsened at 3 months | 4.3 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status no change at 1 month | 39 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status worsened at 7 days | 0 percentage of participants |
| Non Surgical Management | Ambulatory Status Change | Ambulatory status no change at 12 months | 17 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status worsened at 7 days | 5.3 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status improved at 1 month | 11 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status no change at 1 month | 87 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status worsened at 6 months | 7.9 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status worsened at 1 month | 2.6 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status improved at 3 months | 16 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status no change at 12 months | 53 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status no change at 3 months | 76 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status worsened at 3 months | 2.6 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status improved at 12 months | 16 percentage of participants |
| Crossover | Ambulatory Status Change | Full ambulatory at baseline | 55 percentage of participants |
| Crossover | Ambulatory Status Change | Assisted ambulatory at baseline | 39 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status improved at 6 months | 16 percentage of participants |
| Crossover | Ambulatory Status Change | Not ambulatory at baseline | 5.3 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status worsened at 12 months | 2.6 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status improved at 7 days | 7.9 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status no change at 7 days | 87 percentage of participants |
| Crossover | Ambulatory Status Change | Ambulatory status no change at 6 months | 63 percentage of participants |
Secondary
Ambulatory Status Change From Baseline to One Month
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Time frame: 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Ambulatory Status Change From Baseline to One Month | Fully ambulatory at baseline | 56 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change From Baseline to One Month | Assisted ambulatory | 32 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change From Baseline to One Month | Not ambulatory | 10 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change From Baseline to One Month | Ambulatory status improved at 1 month | 16 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change From Baseline to One Month | No change in ambulatory status at 1 month | 74 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status Change From Baseline to One Month | Ambulatory status worsened at 1 month | 2.9 percentage of participants |
| Non Surgical Management | Ambulatory Status Change From Baseline to One Month | No change in ambulatory status at 1 month | 66 percentage of participants |
| Non Surgical Management | Ambulatory Status Change From Baseline to One Month | Fully ambulatory at baseline | 56 percentage of participants |
| Non Surgical Management | Ambulatory Status Change From Baseline to One Month | Ambulatory status improved at 1 month | 6.6 percentage of participants |
| Non Surgical Management | Ambulatory Status Change From Baseline to One Month | Assisted ambulatory | 34 percentage of participants |
| Non Surgical Management | Ambulatory Status Change From Baseline to One Month | Ambulatory status worsened at 1 month | 9.8 percentage of participants |
| Non Surgical Management | Ambulatory Status Change From Baseline to One Month | Not ambulatory | 8.2 percentage of participants |
Secondary
Back Pain Analgesics Used
Time frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at baseline | 96 percentage of participants |
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at 7 days | 82 percentage of participants |
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at 1 month | 60 percentage of participants |
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at 3 months | 43 percentage of participants |
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at 6 months | 40 percentage of participants |
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at 12 months | 19 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at 12 months | 13 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at baseline | 78 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at 3 months | 30 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at 6 months | 22 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at 7 days | 61 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at 1 month | 39 percentage of participants |
| Crossover | Back Pain Analgesics Used | Back pain analgesic use at 7 days | 68 percentage of participants |
| Crossover | Back Pain Analgesics Used | Back pain analgesic use at 1 month | 66 percentage of participants |
| Crossover | Back Pain Analgesics Used | Back pain analgesic use at 12 months | 26 percentage of participants |
| Crossover | Back Pain Analgesics Used | Back pain analgesic use at 3 months | 58 percentage of participants |
| Crossover | Back Pain Analgesics Used | Back pain analgesic use at baseline | 87 percentage of participants |
| Crossover | Back Pain Analgesics Used | Back pain analgesic use at 6 months | 39 percentage of participants |
Secondary
Back Pain Analgesics Used
Time frame: Baseline, 7 days, and 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at baseline | 96 percentage of participants |
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at 7 days | 82 percentage of participants |
| Balloon Kyphoplasty | Back Pain Analgesics Used | Back pain analgesic use at 1 month | 60 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at baseline | 84 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at 7 days | 80 percentage of participants |
| Non Surgical Management | Back Pain Analgesics Used | Back pain analgesic use at 1 month | 72 percentage of participants |
Secondary
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
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.
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at baseline | 90 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at baseline | 8.8 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't known at baseline | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 1 month | 56 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 1 month | 38 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 1 month | 0 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 1 month | 6.6 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at baseline | 97 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 1 month | 75 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at baseline | 1.6 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 1 month | 0 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't known at baseline | 0 percentage of participants |
Secondary
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
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.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 1 month | 0 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't known at baseline | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 6 months | 38 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 3 months | 37 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at baseline | 8.8 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 6 months | 34 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 3 months | 43 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 12 months | 19 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 3 months | 0 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 1 month | 56 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 12 months | 0 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at baseline | 90 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 1 month | 38 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 12 months | 40 percentage of participants |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 6 months | 0 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 6 months | 0 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at baseline | 96 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at baseline | 4.3 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't known at baseline | 0 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 1 month | 48 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 1 month | 4.3 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 1 month | 0 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 3 months | 39 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 3 months | 4.3 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 3 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 6 months | 26 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 6 months | 8.7 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 12 months | 17 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 12 months | 8.7 percentage of participants |
| Non Surgical Management | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 12 months | 0 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 1 month | 0 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 12 months | 32 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 6 months | 55 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 1 month | 47 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 1 month | 53 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 6 months | 0 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't known at baseline | 0.0 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at baseline | 97 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 12 months | 39 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at 3 months | 58 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | No activities reduced at baseline | 2.6 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 3 months | 2.6 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 3 months | 34 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Don't know at 12 months | 0 percentage of participants |
| Crossover | Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks | Activities reduced at 6 months | 32 percentage of participants |
Secondary
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
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.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 12 months | -5.8 days | Standard Deviation 6.3 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Baseline | 6.3 days | Standard Deviation 6.3 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 6 months | -3.8 days | Standard Deviation 7.6 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 3 months | -3.4 days | Standard Deviation 7.7 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 month | -4.0 days | Standard Deviation 7.7 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 3 months | -4.8 days | Standard Deviation 6 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 6 months | -4.1 days | Standard Deviation 7.8 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Baseline | 8.1 days | Standard Deviation 5.9 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 month | -0.2 days | Standard Deviation 5.9 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 12 months | -4.3 days | Standard Deviation 6.2 |
| Crossover | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 12 months | -4.7 days | Standard Deviation 6.8 |
| Crossover | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 month | -4.5 days | Standard Deviation 6 |
| Crossover | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 3 months | -5.0 days | Standard Deviation 6.1 |
| Crossover | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Baseline | 5.8 days | Standard Deviation 6 |
| Crossover | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 6 months | -5.7 days | Standard Deviation 5.9 |
Secondary
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
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.
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Baseline | 6.3 days | Standard Deviation 6.3 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 month | -4.0 days | Standard Deviation 7.7 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Baseline | 6.8 days | Standard Deviation 6 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 month | 0.2 days | Standard Deviation 4.7 |
Secondary
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
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.
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Baseline | 10.8 days | Standard Deviation 4.9 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to one month | -5.2 days | Standard Deviation 7.1 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Baseline | 11.5 days | Standard Deviation 4.3 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to one month | 1.1 days | Standard Deviation 4.5 |
Secondary
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
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.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 3 months | -5.5 days | Standard Deviation 7 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 12 months | -7.8 days | Standard Deviation 6.4 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 6 months | -5.0 days | Standard Deviation 7.9 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Baseline | 10.8 days | Standard Deviation 4.9 |
| Balloon Kyphoplasty | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 months | -5.2 days | Standard Deviation 7.1 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 months | -0.4 days | Standard Deviation 3.3 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 3 months | -1.8 days | Standard Deviation 6.3 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Baseline | 12.0 days | Standard Deviation 3.6 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 12 months | -5.2 days | Standard Deviation 5.2 |
| Non Surgical Management | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 6 months | -2.9 days | Standard Deviation 7.9 |
| Crossover | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 12 months | -7.4 days | Standard Deviation 7.3 |
| Crossover | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 3 months | -7.4 days | Standard Deviation 7.1 |
| Crossover | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 6 months | -8.5 days | Standard Deviation 5.2 |
| Crossover | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Baseline | 11.0 days | Standard Deviation 4.8 |
| Crossover | Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks | Change from baseline to 1 months | -5.6 days | Standard Deviation 7.2 |
Secondary
Change in Back Pain
Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Back Pain | Back pain at baseline | 7.3 units on a scale | Standard Deviation 1.6 |
| Balloon Kyphoplasty | Change in Back Pain | Change from baseline to 7 days | -3.8 units on a scale | Standard Deviation 3 |
| Balloon Kyphoplasty | Change in Back Pain | Change from baseline to 1 month | -3.9 units on a scale | Standard Deviation 3.2 |
| Balloon Kyphoplasty | Change in Back Pain | Change from baseline to 3 months | -3.6 units on a scale | Standard Deviation 3.3 |
| Balloon Kyphoplasty | Change in Back Pain | Change from baseline to 6 months | -3.7 units on a scale | Standard Deviation 3.2 |
| Balloon Kyphoplasty | Change in Back Pain | Change from baseline to 12 months | -3.9 units on a scale | Standard Deviation 3.2 |
| Non Surgical Management | Change in Back Pain | Change from baseline to 12 months | -3.0 units on a scale | Standard Deviation 3.2 |
| Non Surgical Management | Change in Back Pain | Back pain at baseline | 6.8 units on a scale | Standard Deviation 1.5 |
| Non Surgical Management | Change in Back Pain | Change from baseline to 3 months | -2.1 units on a scale | Standard Deviation 2.1 |
| Non Surgical Management | Change in Back Pain | Change from baseline to 6 months | -2.4 units on a scale | Standard Deviation 3.9 |
| Non Surgical Management | Change in Back Pain | Change from baseline to 7 days | -0.7 units on a scale | Standard Deviation 1.8 |
| Non Surgical Management | Change in Back Pain | Change from baseline to 1 month | -0.9 units on a scale | Standard Deviation 2 |
| Crossover | Change in Back Pain | Change from baseline to 7 days | -4.0 units on a scale | Standard Deviation 3.1 |
| Crossover | Change in Back Pain | Change from baseline to 1 month | -4.1 units on a scale | Standard Deviation 2.9 |
| Crossover | Change in Back Pain | Change from baseline to 12 months | -4.9 units on a scale | Standard Deviation 3 |
| Crossover | Change in Back Pain | Change from baseline to 3 months | -4.3 units on a scale | Standard Deviation 2.8 |
| Crossover | Change in Back Pain | Back pain at baseline | 7.6 units on a scale | Standard Deviation 1.4 |
| Crossover | Change in Back Pain | Change from baseline to 6 months | -4.8 units on a scale | Standard Deviation 2.9 |
Secondary
Change in Back Pain
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Back Pain | Baseline | 7.3 units on a scale | Standard Deviation 1.6 |
| Balloon Kyphoplasty | Change in Back Pain | 1 month | 3.3 units on a scale | Standard Deviation 2.8 |
| Balloon Kyphoplasty | Change in Back Pain | Change from baseline to 1 month | -3.9 units on a scale | Standard Deviation 3.2 |
| Non Surgical Management | Change in Back Pain | Baseline | 7.3 units on a scale | Standard Deviation 1.4 |
| Non Surgical Management | Change in Back Pain | 1 month | 6.9 units on a scale | Standard Deviation 1.5 |
| Non Surgical Management | Change in Back Pain | Change from baseline to 1 month | -0.6 units on a scale | Standard Deviation 1.8 |
Secondary
Change in Functional Status Assessed With the Karnofsky Performance Scale
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 6 months | 18.0 units on a scale | Standard Deviation 23.1 |
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 3 months | 18.0 units on a scale | Standard Deviation 23.8 |
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Baseline score | 57.1 units on a scale | Standard Deviation 18 |
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 1 month | 15.9 units on a scale | Standard Deviation 21.2 |
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 12 months | 23.0 units on a scale | Standard Deviation 25.2 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 3 months | 10.0 units on a scale | Standard Deviation 16.3 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Baseline score | 55.0 units on a scale | Standard Deviation 17.7 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 1 month | 0.0 units on a scale | Standard Deviation 14.1 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 6 months | 12.5 units on a scale | Standard Deviation 21.2 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 12 months | 21.7 units on a scale | Standard Deviation 23.2 |
| Crossover | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 12 months | 22.2 units on a scale | Standard Deviation 18 |
| Crossover | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 6 months | 23.3 units on a scale | Standard Deviation 19.8 |
| Crossover | Change in Functional Status Assessed With the Karnofsky Performance Scale | Baseline score | 58.7 units on a scale | Standard Deviation 14.6 |
| Crossover | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 3 months | 21.1 units on a scale | Standard Deviation 19.1 |
| Crossover | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to 1 month | 19.2 units on a scale | Standard Deviation 20.6 |
Secondary
Change in Functional Status Assessed With the Karnofsky Performance Scale
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Baseline score | 57.1 units on a scale | Standard Deviation 18 |
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Score at 1 month | 73.2 units on a scale | Standard Deviation 15.5 |
| Balloon Kyphoplasty | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to one month | 15.9 units on a scale | Standard Deviation 21.2 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Baseline score | 57.3 units on a scale | Standard Deviation 15.8 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Score at 1 month | 58.6 units on a scale | Standard Deviation 16.2 |
| Non Surgical Management | Change in Functional Status Assessed With the Karnofsky Performance Scale | Change from baseline to one month | 0.6 units on a scale | Standard Deviation 11.6 |
Secondary
Change in Neurological Status From Baseline (Limb Strength)
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).
Time frame: 1 months, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 1 month | 81 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Improved at 3 months | 4.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Improved at 1 month | 12 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 1 month | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 3 months | 71 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 3 months | 4.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Improved at 6 months | 7.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 6 months | 63 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 6 months | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Improved at 12 months | 4.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 12 months | 51 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 12 months | 2.9 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 12 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 6 months | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Improved at 3 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Improved at 6 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Improved at 1 month | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 3 months | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 1 month | 48 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 12 months | 22 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 6 months | 30 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 1 month | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 3 months | 39 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Improved at 12 months | 4.3 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Improved at 3 months | 13 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 3 months | 79 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Improved at 12 months | 11 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 3 months | 2.6 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Improved at 6 months | 13 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 6 months | 71 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 12 months | 58 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 6 months | 2.6 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Improved at 1 month | 16 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Unchanged at 1 month | 82 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 12 months | 2.6 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Limb Strength) | Worsened at 1 month | 0.0 percentage of participants |
Secondary
Change in Neurological Status From Baseline (Limb Strength)
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).
Time frame: 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Improved | 12 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Unchanged | 81 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Limb Strength) | Worsened | 1.5 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Improved | 4.9 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Worsened | 8.2 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Limb Strength) | Unchanged | 67 percentage of participants |
Secondary
Change in Neurological Status From Baseline (Reflex Strength)
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
Time frame: 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Improved | 7.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged | 85 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Worsened | 1.5 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Improved | 8.2 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged | 69 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Worsened | 3.3 percentage of participants |
Secondary
Change in Neurological Status From Baseline (Reflex Strength)
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
Time frame: 1 months, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 3 months | 2.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 3 months | 2.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 6 months | 5.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 3 months | 74 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 6 months | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 12 months | 53 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 1 month | 7.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 1 month | 85 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 12 months | 2.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 6 months | 65 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 1 month | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 12 months | 2.9 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 1 month | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 1 month | 43 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 1 month | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 3 months | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 3 months | 39 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 3 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 6 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 6 months | 35 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 6 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 12 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 12 months | 26 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 12 months | 0.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 12 months | 0.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 6 months | 71 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 12 months | 63 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 6 months | 7.9 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 3 months | 2.6 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 3 months | 82 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 1 month | 11.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 1 month | 5.3 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Worsened at 3 months | 11.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 12 months | 7.9 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Improved at 6 months | 7.9 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Reflex Strength) | Unchanged at 1 month | 82 percentage of participants |
Secondary
Change in Neurological Status From Baseline (Sensory Examination)
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Improved | 2.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged | 91 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Worsened | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Improved | 1.6 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged | 79 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Worsened | 0.0 percentage of participants |
Secondary
Change in Neurological Status From Baseline (Sensory Examination)
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.
Time frame: 1 months, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 1 month | 2.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 1 month | 91 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 1 month | 0.0 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 3 months | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 3 months | 78 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 3 months | 0.0 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 6 months | 0.0 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 6 months | 71 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 6 months | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 12 months | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 12 months | 57 percentage of participants |
| Balloon Kyphoplasty | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 12 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 12 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 1 month | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 6 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 6 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 1 month | 52 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 3 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 12 months | 22 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 1 month | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 6 months | 35 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 3 months | 43 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 3 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 12 months | 4.3 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 3 months | 2.6 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 3 months | 92 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 12 months | 0.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 3 months | 0.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 6 months | 2.6 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 6 months | 84 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 12 months | 66 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Improved at 1 month | 2.6 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Unchanged at 1 month | 95 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 6 months | 0.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 1 month | 0.0 percentage of participants |
| Crossover | Change in Neurological Status From Baseline (Sensory Examination) | Worsened at 12 months | 5.3 percentage of participants |
Secondary
Change in Neurology Status From Baseline (Motor Strength)
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
Time frame: 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength) | Improved at 1 month | 8.8 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength) | Unchanged at 1 month | 84 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength) | Worsened at 1 month | 1.5 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength) | Improved at 1 month | 3.3 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength) | Unchanged at 1 month | 74 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength) | Worsened at 1 month | 3.3 percentage of participants |
Secondary
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
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
Time frame: 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at in month | 1.5 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 1 month | 8.8 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 1 month | 84 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 3 months | 7.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 3 months | 68 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 3 months | 2.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 6 months | 5.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 6 months | 62 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 6 months | 4.4 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 12 months | 2.9 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 12 months | 53 percentage of participants |
| Balloon Kyphoplasty | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 12 months | 2.9 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 12 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at in month | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 6 months | 0.0 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 1 month | 8.7 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 6 months | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 3 months | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 1 month | 39 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 12 months | 22 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 6 months | 30 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 3 months | 35 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 3 months | 4.3 percentage of participants |
| Non Surgical Management | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 12 months | 4.3 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 3 months | 7.9 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 3 months | 84 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 12 months | 5.3 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 3 months | 2.6 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 6 months | 11 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 6 months | 68 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 12 months | 66 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Improved at 1 month | 2.6 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 6 months | 7.9 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Unchanged at 1 month | 92 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at in month | 2.6 percentage of participants |
| Crossover | Change in Neurology Status From Baseline (Motor Strength)-Per Protocol | Worsened at 12 months | 0.0 percentage of participants |
Secondary
Change in Quality of Life
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.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Quality of Life | MCS change from baseline to 1 month | 9.2 units on a scale | Standard Deviation 14.6 |
| Balloon Kyphoplasty | Change in Quality of Life | SF-36 PCS at baseline | 25.4 units on a scale | Standard Deviation 6 |
| Balloon Kyphoplasty | Change in Quality of Life | MCS change from baseline to 3 months | 7.6 units on a scale | Standard Deviation 15 |
| Balloon Kyphoplasty | Change in Quality of Life | MCS change from baseline to 6 months | 8.5 units on a scale | Standard Deviation 15.2 |
| Balloon Kyphoplasty | Change in Quality of Life | MCS change from baseline to 12 months | 7.8 units on a scale | Standard Deviation 15.5 |
| Balloon Kyphoplasty | Change in Quality of Life | PCS change from baseline to 6 months | 9.1 units on a scale | Standard Deviation 9.1 |
| Balloon Kyphoplasty | Change in Quality of Life | PCS change from baseline to 3 months | 10.0 units on a scale | Standard Deviation 11.1 |
| Balloon Kyphoplasty | Change in Quality of Life | PCS change from baseline to 12 months | 11.7 units on a scale | Standard Deviation 10.3 |
| Balloon Kyphoplasty | Change in Quality of Life | PCS change from baseline to 1 months | 9.4 units on a scale | Standard Deviation 9.4 |
| Balloon Kyphoplasty | Change in Quality of Life | SF-36 MCS at baseline | 38.2 units on a scale | Standard Deviation 13.3 |
| Non Surgical Management | Change in Quality of Life | PCS change from baseline to 1 months | -0.2 units on a scale | Standard Deviation 4.2 |
| Non Surgical Management | Change in Quality of Life | PCS change from baseline to 6 months | -0.8 units on a scale | Standard Deviation 6.2 |
| Non Surgical Management | Change in Quality of Life | MCS change from baseline to 1 month | -1.1 units on a scale | Standard Deviation 12.4 |
| Non Surgical Management | Change in Quality of Life | MCS change from baseline to 3 months | 7.3 units on a scale | Standard Deviation 13.4 |
| Non Surgical Management | Change in Quality of Life | SF-36 MCS at baseline | 36.0 units on a scale | Standard Deviation 14.7 |
| Non Surgical Management | Change in Quality of Life | MCS change from baseline to 6 months | 4.3 units on a scale | Standard Deviation 12.1 |
| Non Surgical Management | Change in Quality of Life | PCS change from baseline to 3 months | 1.1 units on a scale | Standard Deviation 6.4 |
| Non Surgical Management | Change in Quality of Life | PCS change from baseline to 12 months | 1.3 units on a scale | Standard Deviation 9.1 |
| Non Surgical Management | Change in Quality of Life | MCS change from baseline to 12 months | 5.6 units on a scale | Standard Deviation 12.5 |
| Non Surgical Management | Change in Quality of Life | SF-36 PCS at baseline | 25.3 units on a scale | Standard Deviation 4.8 |
| Crossover | Change in Quality of Life | MCS change from baseline to 12 months | 9.2 units on a scale | Standard Deviation 17.1 |
| Crossover | Change in Quality of Life | SF-36 PCS at baseline | 24.5 units on a scale | Standard Deviation 7.2 |
| Crossover | Change in Quality of Life | PCS change from baseline to 1 months | 9.1 units on a scale | Standard Deviation 9.5 |
| Crossover | Change in Quality of Life | PCS change from baseline to 3 months | 11.1 units on a scale | Standard Deviation 9.3 |
| Crossover | Change in Quality of Life | PCS change from baseline to 6 months | 10.8 units on a scale | Standard Deviation 9.2 |
| Crossover | Change in Quality of Life | PCS change from baseline to 12 months | 11.9 units on a scale | Standard Deviation 7.9 |
| Crossover | Change in Quality of Life | SF-36 MCS at baseline | 38.1 units on a scale | Standard Deviation 12.7 |
| Crossover | Change in Quality of Life | MCS change from baseline to 1 month | 6.8 units on a scale | Standard Deviation 15.9 |
| Crossover | Change in Quality of Life | MCS change from baseline to 6 months | 13.1 units on a scale | Standard Deviation 15.5 |
| Crossover | Change in Quality of Life | MCS change from baseline to 3 months | 9.2 units on a scale | Standard Deviation 17 |
Secondary
Change in Quality of Life.
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.
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Quality of Life. | SF-36 PCS at baseline | 25.4 units on a scale | Standard Deviation 6 |
| Balloon Kyphoplasty | Change in Quality of Life. | SF-36 PCS at 1 month | 35.2 units on a scale | Standard Deviation 10.1 |
| Balloon Kyphoplasty | Change in Quality of Life. | PCS change from baseline to 1 month | 9.4 units on a scale | Standard Deviation 9.4 |
| Balloon Kyphoplasty | Change in Quality of Life. | SF-36 MCS at baseline | 38.2 units on a scale | Standard Deviation 13.3 |
| Balloon Kyphoplasty | Change in Quality of Life. | SF-36 MCS at 1 month | 46.4 units on a scale | Standard Deviation 13 |
| Balloon Kyphoplasty | Change in Quality of Life. | MCS change from baseline to 1 month | 9.2 units on a scale | Standard Deviation 14.6 |
| Non Surgical Management | Change in Quality of Life. | SF-36 MCS at 1 month | 36.1 units on a scale | Standard Deviation 13.6 |
| Non Surgical Management | Change in Quality of Life. | SF-36 PCS at baseline | 24.8 units on a scale | Standard Deviation 6.4 |
| Non Surgical Management | Change in Quality of Life. | SF-36 MCS at baseline | 37.3 units on a scale | Standard Deviation 13.4 |
| Non Surgical Management | Change in Quality of Life. | SF-36 PCS at 1 month | 26.0 units on a scale | Standard Deviation 6.3 |
| Non Surgical Management | Change in Quality of Life. | MCS change from baseline to 1 month | -1.9 units on a scale | Standard Deviation 12.7 |
| Non Surgical Management | Change in Quality of Life. | PCS change from baseline to 1 month | 1.0 units on a scale | Standard Deviation 6 |
Secondary
Change in Roland-Morris Disability Questionnaire Score
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).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 6 months | -8.2 units on a scale | Standard Deviation 6 |
| Balloon Kyphoplasty | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 3 months | -8.9 units on a scale | Standard Deviation 7 |
| Balloon Kyphoplasty | Change in Roland-Morris Disability Questionnaire Score | RMDQ score at baseline | 17.6 units on a scale | Standard Deviation 3.9 |
| Balloon Kyphoplasty | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 1 months | -8.3 units on a scale | Standard Deviation 7.6 |
| Balloon Kyphoplasty | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 12 months | -9.7 units on a scale | Standard Deviation 6.4 |
| Non Surgical Management | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 3 months | -2.7 units on a scale | Standard Deviation 6.1 |
| Non Surgical Management | Change in Roland-Morris Disability Questionnaire Score | RMDQ score at baseline | 17.9 units on a scale | Standard Deviation 4.2 |
| Non Surgical Management | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 1 months | 0.3 units on a scale | Standard Deviation 3.1 |
| Non Surgical Management | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 6 months | -3.6 units on a scale | Standard Deviation 9.4 |
| Non Surgical Management | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 12 months | -4.5 units on a scale | Standard Deviation 11.4 |
| Crossover | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 12 months | -10.4 units on a scale | Standard Deviation 6 |
| Crossover | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 6 months | -10.8 units on a scale | Standard Deviation 6.1 |
| Crossover | Change in Roland-Morris Disability Questionnaire Score | RMDQ score at baseline | 18.3 units on a scale | Standard Deviation 2.6 |
| Crossover | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 3 months | -10.2 units on a scale | Standard Deviation 6.1 |
| Crossover | Change in Roland-Morris Disability Questionnaire Score | Change from baseline to 1 months | -7.3 units on a scale | Standard Deviation 6.8 |
Secondary
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
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.
Time frame: Baseline, post-operation, 1 month, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at 1 month | 1.126 degrees | Standard Deviation 5.639 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at 12 months | 0.988 degrees | Standard Deviation 8.947 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle at baseline | 9.523 degrees | Standard Deviation 8.751 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at post-op | -0.506 degrees | Standard Deviation 4.231 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle at baseline | -32.335 degrees | Standard Deviation 16.41 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at 12 month | 0.954 degrees | Standard Deviation 5.626 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 at baseline | 22.914 degrees | Standard Deviation 12.72 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at post-op | -0.472 degrees | Standard Deviation 5.617 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at 12 months | 0.005 degrees | Standard Deviation 4.925 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at 12 months | 1.232 degrees | Standard Deviation 7.785 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at 1 month | 0.626 degrees | Standard Deviation 7.075 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at post-op | -1.834 degrees | Standard Deviation 7.886 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle at baseline | 50.976 degrees | Standard Deviation 17.316 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at 1 month | 0.117 degrees | Standard Deviation 5.694 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 at baseline | -7.715 degrees | Standard Deviation 15.47 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at post-op | -1.804 degrees | Standard Deviation 9.701 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at 1 month | 0.135 degrees | Standard Deviation 5.088 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at 12 months | 1.550 degrees | Standard Deviation 5.525 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at 1 month | 0.666 degrees | Standard Deviation 9.253 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at post-operation | 1.312 degrees | Standard Deviation 4.909 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at post-op | NA degrees | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle at baseline | 10.806 degrees | Standard Deviation 8.962 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at post-operation | NA degrees | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at 1 month | -0.130 degrees | Standard Deviation 4.203 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at 12 month | -1.246 degrees | Standard Deviation 3.404 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle at baseline | 53.148 degrees | Standard Deviation 15.837 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at post-op | NA degrees | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at 1 month | -1.633 degrees | Standard Deviation 8.212 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at 12 months | 0.062 degrees | Standard Deviation 7.332 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle at baseline | -31.218 degrees | Standard Deviation 12.656 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at post-op | NA degrees | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at 1 month | 5.661 degrees | Standard Deviation 10.117 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at 12 months | -1.412 degrees | Standard Deviation 3.634 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 at baseline | 23.519 degrees | Standard Deviation 11.363 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at post-op | NA degrees | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at 1 month | 0.357 degrees | Standard Deviation 7.731 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at 12 months | 1.638 degrees | Standard Deviation 1.998 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 at baseline | -6.581 degrees | Standard Deviation 9.957 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at 1 month | -0.105 degrees | Standard Deviation 5.106 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at 12 months | -0.346 degrees | Standard Deviation 3.197 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at post-operation | 1.438 degrees | Standard Deviation 4.191 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at post-op | -2.080 degrees | Standard Deviation 5.311 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at 1 month | -0.457 degrees | Standard Deviation 5.682 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at 12 months | -1.157 degrees | Standard Deviation 3.604 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at 1 month | -0.746 degrees | Standard Deviation 5.23 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at post-op | -2.489 degrees | Standard Deviation 4.823 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at 1 month | -0.770 degrees | Standard Deviation 3.376 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 change at 12 months | -1.333 degrees | Standard Deviation 4.781 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle at baseline | 52.812 degrees | Standard Deviation 19.671 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle at baseline | 11.005 degrees | Standard Deviation 8.798 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 at baseline | -6.945 degrees | Standard Deviation 14.496 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at 12 month | 0.824 degrees | Standard Deviation 4.425 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at 1 month | 0.839 degrees | Standard Deviation 5.336 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at post-op | -1.396 degrees | Standard Deviation 4.575 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Kyphotic angle change at 1 month | 0.637 degrees | Standard Deviation 4.545 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle change at 12 months | 2.057 degrees | Standard Deviation 13.535 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Lumbar cobb angle at baseline | -32.906 degrees | Standard Deviation 15.718 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of L2-L4 change at post-op | -0.610 degrees | Standard Deviation 4.094 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Local cobb angle of T5-L1 at baseline | 23.847 degrees | Standard Deviation 15.945 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Angles | Thoracic cobb angle change at 12 months | -1.372 degrees | Standard Deviation 6.187 |
Secondary
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 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.
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Kyphotic angle at baseline | 9.523 degrees | Standard Deviation 8.751 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Kyphotic angle change at 1 month | 0.135 degrees | Standard Deviation 5.088 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Thoracic cobb angle at baseline | 50.976 degrees | Standard Deviation 17.316 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Thoracic cobb angle change to one month | 0.666 degrees | Standard Deviation 9.253 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Lumbar cobb angle at baseline | -32.335 degrees | Standard Deviation 16.41 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Lumbar cobb angle change at 1 month | 0.626 degrees | Standard Deviation 7.075 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local Cobb angel of T5-L1 at baseline | 22.914 degrees | Standard Deviation 12.72 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local cobb angle of T5-L1 change at 1 month | 1.126 degrees | Standard Deviation 5.639 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local cobb angle of L2-L4 at baseline | -7.715 degrees | Standard Deviation 15.47 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local cobb angle of L2-L4 change at 1 month | 0.117 degrees | Standard Deviation 5.694 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local cobb angle of T5-L1 change at 1 month | 1.608 degrees | Standard Deviation 5.631 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Kyphotic angle at baseline | 10.501 degrees | Standard Deviation 8.833 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Lumbar cobb angle change at 1 month | 2.883 degrees | Standard Deviation 7.634 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Kyphotic angle change at 1 month | -0.598 degrees | Standard Deviation 3.442 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local cobb angle of L2-L4 change at 1 month | -1.149 degrees | Standard Deviation 5.576 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Thoracic cobb angle at baseline | 51.390 degrees | Standard Deviation 19.621 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local Cobb angel of T5-L1 at baseline | 22.792 degrees | Standard Deviation 15.191 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Thoracic cobb angle change to one month | -0.012 degrees | Standard Deviation 8.15 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Local cobb angle of L2-L4 at baseline | -8.291 degrees | Standard Deviation 14.662 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month | Lumbar cobb angle at baseline | -33.101 degrees | Standard Deviation 15.179 |
Secondary
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
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.
Time frame: Baseline, post-operation, 1 month, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at post-op | 0.060 ratio | Standard Deviation 0.117 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 12 months | 0.018 ratio | Standard Deviation 0.11 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR at baseline | 0.782 ratio | Standard Deviation 0.193 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR at baseline | 0.744 ratio | Standard Deviation 0.228 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 1 month | 0.028 ratio | Standard Deviation 0.103 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at post-op | 0.044 ratio | Standard Deviation 0.099 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR at baseline | 0.928 ratio | Standard Deviation 0.101 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at 1 month | 0.007 ratio | Standard Deviation 0.081 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 1 month | 0.016 ratio | Standard Deviation 0.123 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at 12 months | -0.001 ratio | Standard Deviation 0.077 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at post-op | 0.007 ratio | Standard Deviation 0.064 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 12 months | 0.022 ratio | Standard Deviation 0.129 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at post-op | NA ratio | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR at baseline | 0.899 ratio | Standard Deviation 0.166 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR at baseline | 0.767 ratio | Standard Deviation 0.254 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at post-op | NA ratio | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 1 month | -0.036 ratio | Standard Deviation 0.054 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 12 months | -0.022 ratio | Standard Deviation 0.072 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR at baseline | 0.741 ratio | Standard Deviation 0.239 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 1 month | -0.031 ratio | Standard Deviation 0.074 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 12 months | 0.021 ratio | Standard Deviation 0.117 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at post-op | NA ratio | — |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at 1 month | -0.022 ratio | Standard Deviation 0.045 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at 12 months | -0.026 ratio | Standard Deviation 0.049 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at 1 month | 0.016 ratio | Standard Deviation 0.069 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 12 months | 0.049 ratio | Standard Deviation 0.087 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR at baseline | 0.951 ratio | Standard Deviation 0.11 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 1 month | 0.006 ratio | Standard Deviation 0.065 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR at baseline | 0.741 ratio | Standard Deviation 0.224 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at post-op | -0.006 ratio | Standard Deviation 0.059 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at post-op | 0.024 ratio | Standard Deviation 0.084 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at post-op | 0.019 ratio | Standard Deviation 0.075 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR at baseline | 0.800 ratio | Standard Deviation 0.176 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR change at 12 months | 0.006 ratio | Standard Deviation 0.053 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 1 month | 0.012 ratio | Standard Deviation 0.071 |
| Crossover | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 12 months | 0.039 ratio | Standard Deviation 0.145 |
Secondary
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
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.
Time frame: Baseline and 1 month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR at baseline | 0.744 ratio | Standard Deviation 0.228 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 1 month | 0.016 ratio | Standard Deviation 0.123 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR at baseline | 0.782 ratio | Standard Deviation 0.193 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 1 month | 0.028 ratio | Standard Deviation 0.103 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR at baseline | 0.928 ratio | Standard Deviation 0.101 |
| Balloon Kyphoplasty | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior change at 1 month | 0.007 ratio | Standard Deviation 0.081 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior VBHR at baseline | 0.934 ratio | Standard Deviation 0.11 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR at baseline | 0.734 ratio | Standard Deviation 0.237 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR change at 1 month | -0.017 ratio | Standard Deviation 0.068 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Anterior VBHR change at 1 month | -0.027 ratio | Standard Deviation 0.061 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Posterior change at 1 month | -0.012 ratio | Standard Deviation 0.058 |
| Non Surgical Management | Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio | Medial VBHR at baseline | 0.776 ratio | Standard Deviation 0.19 |
Secondary
Rate of Study Treatment-related Adverse Events Till Study Completion
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.
Time frame: 12 months
Population: All of randomized subjects were included in safety population analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Till Study Completion | Unrelated | 77 percentage of participants |
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Till Study Completion | Possibly related | 1.4 percentage of participants |
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Till Study Completion | Related | 4.3 percentage of participants |
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Till Study Completion | Unknown | 10 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Till Study Completion | Possibly related | 0 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Till Study Completion | Related | 0 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Till Study Completion | Unknown | 0 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Till Study Completion | Unrelated | 50 percentage of participants |
| Crossover | Rate of Study Treatment-related Adverse Events Till Study Completion | Related | 0 percentage of participants |
| Crossover | Rate of Study Treatment-related Adverse Events Till Study Completion | Possibly related | 0 percentage of participants |
| Crossover | Rate of Study Treatment-related Adverse Events Till Study Completion | Unknown | 0 percentage of participants |
| Crossover | Rate of Study Treatment-related Adverse Events Till Study Completion | Unrelated | 37 percentage of participants |
| Crossover-(AEs Collected After BKP) | Rate of Study Treatment-related Adverse Events Till Study Completion | Unknown | 7.9 percentage of participants |
| Crossover-(AEs Collected After BKP) | Rate of Study Treatment-related Adverse Events Till Study Completion | Possibly related | 2.6 percentage of participants |
| Crossover-(AEs Collected After BKP) | Rate of Study Treatment-related Adverse Events Till Study Completion | Unrelated | 79 percentage of participants |
| Crossover-(AEs Collected After BKP) | Rate of Study Treatment-related Adverse Events Till Study Completion | Related | 2.6 percentage of participants |
Secondary
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
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.
Time frame: 1 month
Population: All of the randomized subjects were included in safety population analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Unrelated | 33 percentage of participants |
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Possibly related | 1.4 percentage of participants |
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Related | 4.3 percentage of participants |
| Balloon Kyphoplasty | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Unknown | 2.9 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Unknown | 0 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Unrelated | 30 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Related | 0 percentage of participants |
| Non Surgical Management | Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline | Possibly related | 0 percentage of participants |
Secondary
Rate of Subsequent Vertebral Body Fractures
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Kyphoplasty | Rate of Subsequent Vertebral Body Fractures | 19.6 percentage of participants |
| Non Surgical Management | Rate of Subsequent Vertebral Body Fractures | 17.0 percentage of participants |
Secondary
Rate of Subsequent Vertebral Body Fractures
Based on patients with at least 7 analyzable vertebrae.
Time frame: 1 month and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Rate of Subsequent Vertebral Body Fractures | 1 month | 19.4 percentage of participants |
| Balloon Kyphoplasty | Rate of Subsequent Vertebral Body Fractures | 12 months | 13.2 percentage of participants |
| Non Surgical Management | Rate of Subsequent Vertebral Body Fractures | 1 month | 23.1 percentage of participants |
| Non Surgical Management | Rate of Subsequent Vertebral Body Fractures | 12 months | 0.0 percentage of participants |
| Crossover | Rate of Subsequent Vertebral Body Fractures | 1 month | 11.8 percentage of participants |
| Crossover | Rate of Subsequent Vertebral Body Fractures | 12 months | 7.4 percentage of participants |