Deformity of Spine, Degenerative Spinal Disease
Conditions
Brief summary
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.
Interventions
DEVICECD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A subject must meet the following inclusion criteria to participate in this trial: 1. One or more of the following diagnostic indications: * Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis) * Deformity (e.g. degenerative deformity) 2. Degenerative Spinal Disease patients only: Patient has been unresponsive to non-operative treatment for at least three months or has progressive symptoms or signs of nerve root/spinal cord compression while undergoing continued non-operative management. 3. Compromised bone quality defined as a hip DXA scan T-score less than or equal to -1.0 or spine quantitative CT (qCT) actual volumetric bone mineral density threshold of ≤ 120 mg/cm3. 4. Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization and/or immobilization. 5. Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement. 6. At least 22 years old or greater at the time of informed consent. 7. Is able to understand and willing to sign the Patient Informed Consent Form. 8. Is willing and able to undergo the study procedure and perform the follow up visits.
Exclusion criteria
A subject will be excluded from participating in this trial for any of the following reasons: 1. Has undergone stabilization and/or fusion procedure at the index or adjacent levels. 2. Will undergo vertebroplasty or kyphoplasty procedure during surgery. 3. Has been diagnosed with cauda equina syndrome. 4. Has been previously diagnosed with clinically significant peripheral neuropathy. 5. Has any degree of permanent neurologic deficit due to the presenting spinal disease (e.g. drop foot or gait deficit). 6. Has obesity defined by BMI greater than or equal to 35kg/m2. 7. Has documented allergy to the materials that will be used in the surgical or any imaging procedure (e.g. titanium alloys, cobalt-chromium-molybdenum alloys and PMMA Fenestrated Screw Cement, contrast medium) 8. Has overt or active bacterial infection, local or systemic, and/or potential for bacteremia. 9. Has a non-correctable spontaneous or therapeutic coagulation disorder or history of coagulation disorder associated with bleeding. 10. Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) nonreactive to medical treatment. 11. Has any disease (e.g., neuromuscular disease, etc.) that would preclude the potential benefit and/or accurate clinical evaluation of the safety of the spinal implant surgery. 12. Is pregnant or planning to become pregnant during the study duration. 13. Is illiterate or considered vulnerable as per the Investigator's assessment (e.g., participants incapable of judgment, or participants under tutelage). 14. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results\*.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline | Baseline to 12 months | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery | Surgery to 12 months. | When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery. Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1. |
| Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Baseline, 3, 12 months | Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible. The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported. |
| Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Baseline, 3, 12 months | The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting no health problems, slight health problems, moderate health problems, severe health problems, and extreme health problems. The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems). EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. |
| Rate of Neurological Success at 12-month Visit | Baseline to 12 months. | Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced). Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve). |
| Rate of Intraoperative Cement Extravasation/Leakage. Patients | Surgery to 12 months. | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. |
| Rate of Intraoperative Cement Extravasation/Leakage. Screws | Surgery to 12 months. | The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures. |
| Change in ODI From Baseline at 3 Months Visit | Baseline, 3 months | Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. \[23\]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point. |
| Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Surgery to 12 months. | The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months. The following were considered as signs of instrumentation instability: * Screw pullout * Screw loosening * Screw toggle |
| Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Surgery to 12 months. | The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays. The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (\<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as No fusion success. For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine. |
| For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Baseline to 12 months | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: * Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). * Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS) |
| For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Baseline to 12 months | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: * Coronal alignment : Distance between C7 plumb line and the central sacral vertical line * Sagittal alignment - Global parameter: Sagittal vertical axis (SVA) |
| For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Baseline to 12 months | Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: \- Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: * Curve type L: patients with a lumbar or thoracolumbar major curve \>30˚ (apical level of T10 or lower) * Curve type T: patients with a thoracic major curve of \>30˚ (apical level of T9 or higher) * Curve type D: patients with a double major curve, with each curve \>30˚. * Curve type N: patients with no coronal curve \>30˚. |
| Device and/or Procedure Related Adverse Events Through 12 Months. | Surgery to 12 months. | The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship. For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit. |
Countries
Belgium, Finland, France, Greece, Italy
Participant flow
Recruitment details
The study aimed at evaluating overall 100 subjects with around 50 subjects (no less than 48 subjects) in each indication subgroup at approximately 10 study sites in Europe. Due to the premature closure of the study, the number of enrolled subjects was 27 (16 belonging to the degenerative spinal disease group and 11 to the deformity group) in 6 sites in Europe.
Participants by arm
| Arm | Count |
|---|---|
| Degenerative Spinal Disease Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis). | 11 |
| Deformity Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity). | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month | Early termination cut-off date | 8 | 9 |
| 24 Month | Early termination cut-off date | 1 | 1 |
| 3 Month | Early termination cut-off date | 2 | 0 |
| Enrollment | Protocol Violation | 4 | 1 |
| Surgery | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Degenerative Spinal Disease | Deformity | Total |
|---|---|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 10 | 70.9 years STANDARD_DEVIATION 6.6 | 70.7 years STANDARD_DEVIATION 8.3 |
| Body Max Index (BMI) | 23.9 kg/m^2 STANDARD_DEVIATION 4.1 | 26.4 kg/m^2 STANDARD_DEVIATION 3.6 | 25.1 kg/m^2 STANDARD_DEVIATION 4 |
| Bone Density Assessment | -1.9 T-score STANDARD_DEVIATION 0.8 | -1.9 T-score STANDARD_DEVIATION 0.8 | -1.9 T-score STANDARD_DEVIATION 0.7 |
| Duration of Back Pain Resulting in Planned Surgery | 13.5 months STANDARD_DEVIATION 13.6 | 17.5 months STANDARD_DEVIATION 17.9 | 15.4 months STANDARD_DEVIATION 15.5 |
| Duration of conservative treatment | 21.6 months STANDARD_DEVIATION 49 | 20.9 months STANDARD_DEVIATION 22.7 | 21.3 months STANDARD_DEVIATION 37.8 |
| Duration of Leg Pain Resulting in Planned Surgery | 11.0 months STANDARD_DEVIATION 11.4 | 9.2 months STANDARD_DEVIATION 6.1 | 10.1 months STANDARD_DEVIATION 9.1 |
| Duration of Other Generalized Pain Resulting in Planned Surgery | 0.0 months STANDARD_DEVIATION 0 | 12.0 months STANDARD_DEVIATION 37.9 | 5.7 months STANDARD_DEVIATION 26.2 |
| Height | 159.3 cm STANDARD_DEVIATION 7.3 | 158.6 cm STANDARD_DEVIATION 8.2 | 159.0 cm STANDARD_DEVIATION 7.6 |
| Patients with previous surgeries | 4 participants | 2 participants | 6 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 60.8 Kg STANDARD_DEVIATION 13.3 | 66.6 Kg STANDARD_DEVIATION 10.8 | 63.5 Kg STANDARD_DEVIATION 12.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 1 / 11 | 1 / 10 |
| serious Total, serious adverse events | 1 / 11 | 4 / 10 |
Outcome results
Primary
Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.
Time frame: Baseline to 12 months
Population: Due to the premature termination of the study, the number of subjects who completed the 12 month follow-up visit was very low (N=2/21, 9.5%).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degenerative Spinal Disease | Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline | 46.0 score on a scale |
| Deformity | Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline | 17.8 score on a scale |
Secondary
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting no health problems, slight health problems, moderate health problems, severe health problems, and extreme health problems. The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems). EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported.
Time frame: Baseline, 3, 12 months
Population: The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit.~The 24 months follow-up visit did not have data collected and are not reported. The reported EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_Baseline | 0.24 score on a scale | Standard Deviation 0.25 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_3 Months | 0.66 score on a scale | Standard Deviation 0.37 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_Change from Baseline at 3 Months | 0.43 score on a scale | Standard Deviation 0.36 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_12 Months | 0.910 score on a scale | Standard Deviation 0 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_Change from Baseline at 12 Months | 0.423 score on a scale | Standard Deviation 0 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_Baseline | 64.8 score on a scale | Standard Deviation 20.3 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_3 Months | 72.8 score on a scale | Standard Deviation 21.7 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_Change from Baseline | 11.9 score on a scale | Standard Deviation 35.8 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_12 Months | 90.0 score on a scale | Standard Deviation 0 |
| Degenerative Spinal Disease | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_Change from Baseline at 12 Months | 50.0 score on a scale | Standard Deviation 0 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_Change from Baseline | 24.7 score on a scale | Standard Deviation 20.3 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_Baseline | 0.39 score on a scale | Standard Deviation 0.19 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_Baseline | 57.5 score on a scale | Standard Deviation 15.9 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_3 Months | 0.68 score on a scale | Standard Deviation 0.34 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_Change from Baseline at 12 Months | 20.0 score on a scale | Standard Deviation 0 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_Change from Baseline at 3 Months | 0.28 score on a scale | Standard Deviation 0.33 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_3 Months | 82.2 score on a scale | Standard Deviation 16.5 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_12 Months | 0.910 score on a scale | Standard Deviation 0 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Health State score_12 Months | 70.0 score on a scale | Standard Deviation 0 |
| Deformity | Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline | Index score_Change from Baseline at 12 Months | 0.423 score on a scale | Standard Deviation 0 |
Comparison: To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.p-value: 0.174t-test, 1 sided
Comparison: To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.p-value: 0.002t-test, 1 sided
Comparison: To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.p-value: 0.003t-test, 1 sided
Comparison: To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.p-value: 0.012t-test, 1 sided
Secondary
Change in ODI From Baseline at 3 Months Visit
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. \[23\]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.
Time frame: Baseline, 3 months
Population: The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit.~The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degenerative Spinal Disease | Change in ODI From Baseline at 3 Months Visit | Baseline | 49.7 score on a scale | Standard Deviation 20 |
| Degenerative Spinal Disease | Change in ODI From Baseline at 3 Months Visit | 3 Month | 20.9 score on a scale | Standard Deviation 24.9 |
| Degenerative Spinal Disease | Change in ODI From Baseline at 3 Months Visit | Change from Baseline | 31.5 score on a scale | Standard Deviation 28.9 |
| Deformity | Change in ODI From Baseline at 3 Months Visit | Baseline | 39.6 score on a scale | Standard Deviation 13 |
| Deformity | Change in ODI From Baseline at 3 Months Visit | 3 Month | 23.0 score on a scale | Standard Deviation 21.7 |
| Deformity | Change in ODI From Baseline at 3 Months Visit | Change from Baseline | 16.6 score on a scale | Standard Deviation 19.3 |
Comparison: To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline.p-value: 0.06t-test, 1 sided
Comparison: To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline.p-value: 0.012t-test, 1 sided
Secondary
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible. The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported.
Time frame: Baseline, 3, 12 months
Population: The results are summarized for 21 subjects who were assessed at Baseline,19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.~The 24 months follow-up visit did not have data collected and are not reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_Baseline | 4.9 score on a scale | Standard Deviation 2.9 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_3 Months | 2.0 score on a scale | Standard Deviation 2.8 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_Change from Baseline at 3 Months | 3.3 score on a scale | Standard Deviation 2.6 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_12 Months | 2.0 score on a scale | Standard Deviation 0 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_Change from Baseline at 12 Months | 3.0 score on a scale | Standard Deviation 0 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_Baseline | 7.5 score on a scale | Standard Deviation 2.2 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_3 Months | 0.9 score on a scale | Standard Deviation 1.3 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_Change from Baseline at 3 Months | 6.2 score on a scale | Standard Deviation 2.7 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_12 Months | 0.0 score on a scale | Standard Deviation 0 |
| Degenerative Spinal Disease | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_Change form Baseline at 12 Months | 6.0 score on a scale | Standard Deviation 0 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_Change from Baseline at 3 Months | 5.8 score on a scale | Standard Deviation 2.5 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_Baseline | 6.8 score on a scale | Standard Deviation 2.3 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_Baseline | 7.1 score on a scale | Standard Deviation 2.2 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_3 Months | 1.7 score on a scale | Standard Deviation 1.8 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_Change form Baseline at 12 Months | 1.0 score on a scale | Standard Deviation 0 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_Change from Baseline at 3 Months | 5.1 score on a scale | Standard Deviation 3.2 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_3 Months | 1.3 score on a scale | Standard Deviation 1.8 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_12 Months | 3.0 score on a scale | Standard Deviation 0 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Leg Pain_12 Months | 1.0 score on a scale | Standard Deviation 0 |
| Deformity | Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline | Back Pain_Change from Baseline at 12 Months | 0.0 score on a scale | Standard Deviation 0 |
Comparison: To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline.p-value: 0.002t-test, 1 sided
Comparison: To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline.p-value: <0.001t-test, 1 sided
Comparison: To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline.p-value: <0.001t-test, 1 sided
Comparison: To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline.p-value: <0.001t-test, 1 sided
Secondary
Device and/or Procedure Related Adverse Events Through 12 Months.
The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship. For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.
Time frame: Surgery to 12 months.
Population: 21 subjects were assessed at surgery,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Adverse events up to 12 month follow-up visits are reported in the Outcome Measure Data Table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | Adverse Event (AE) | 2 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | Serious Adverse Event (SAE) | 1 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | Serious Adverse Device Effect (SADE) | 1 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | Unexpected Serious Adverse Device Effect (USADE) | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Procedure | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Access System | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Cage/Interbody | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Anterior Plate | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Bone Grafts and Substitutes | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Rods | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Fenestrated Screw Cement_Investigator assessment | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Fenestrated Screw Cement_Sponsor assessment | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Fenestrated Screw(s) | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to other components of the Fixation (stabilization) System | 1 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to an underlying condition or disease_Investigator assessment | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to an underlying condition or disease_Sponsor assessment | 1 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | Not Related SAEs_Investigator assessment | 0 Events |
| Degenerative Spinal Disease | Device and/or Procedure Related Adverse Events Through 12 Months. | Not Related SAEs_Sponsor assessment | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to other components of the Fixation (stabilization) System | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | Adverse Event (AE) | 8 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Rods | 1 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | Serious Adverse Event (SAE) | 6 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | Not Related SAEs_Sponsor assessment | 1 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | Serious Adverse Device Effect (SADE) | 5 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Fenestrated Screw Cement_Investigator assessment | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | Unexpected Serious Adverse Device Effect (USADE) | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to an underlying condition or disease_Investigator assessment | 2 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Procedure | 5 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Fenestrated Screw Cement_Sponsor assessment | 1 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Access System | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | Not Related SAEs_Investigator assessment | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Cage/Interbody | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Fenestrated Screw(s) | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Anterior Plate | 0 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to an underlying condition or disease_Sponsor assessment | 1 Events |
| Deformity | Device and/or Procedure Related Adverse Events Through 12 Months. | SAEs Related to Bone Grafts and Substitutes | 1 Events |
Secondary
For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: * Coronal alignment : Distance between C7 plumb line and the central sacral vertical line * Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)
Time frame: Baseline to 12 months
Population: 1 subject who completed the 12 month follow-up visit was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Baseline Coronal alignment (mm) | 19.0 mm |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | 12-months Coronal alignment (mm) | 4.0 mm |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | Baseline Sagittal vertical axis (SVA) (mm) | 43.0 mm |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit. | 12-months Sagittal vertical axis (SVA) (mm) | 49.0 mm |
Secondary
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: * Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). * Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)
Time frame: Baseline to 12 months
Population: 1 subject who completed the 12 month follow-up visit was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Baseline Thoracic Kyphosis (TK) (degrees) | 66 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | 12-months Thoracic Kyphosis (TK) (degrees) | 78 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Baseline Thoracolumbar kyphosis (TLK) (degrees) | 41 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | 12-months Thoracolumbar kyphosis (TLK) (degrees) | 5 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Baseline Lumbar lordosis (LL) (degrees) | 50 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | 12-months Lumbar Lordosis (LL) (degrees) | 58 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Baseline Pelvic Incidence (PI) (degrees) | 46 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | 12-months Pelvic Incidence (PI) (degrees) | 50 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Baseline Pelvic Tilt (PT) (degrees) | 23 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | 12-months Pelvic Tilt (PT) (degrees) | 23 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | Baseline Sacral Slope (SS) (degrees) | 23 Degrees |
| Degenerative Spinal Disease | For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. | 12-months Sacral Slope (SS) (degrees) | 27 Degrees |
Secondary
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: \- Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: * Curve type L: patients with a lumbar or thoracolumbar major curve \>30˚ (apical level of T10 or lower) * Curve type T: patients with a thoracic major curve of \>30˚ (apical level of T9 or higher) * Curve type D: patients with a double major curve, with each curve \>30˚. * Curve type N: patients with no coronal curve \>30˚.
Time frame: Baseline to 12 months
Population: 1 subject who completed the 12 month follow-up visit was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Baseline curve type L | 1 Participants |
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | 12-months curve type L | 1 Participants |
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Baseline curve type T | 0 Participants |
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | 12-months curve type T | 0 Participants |
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Baseline curve type D | 0 Participants |
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | 12-months curve type D | 0 Participants |
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | Baseline curve type N | 0 Participants |
| Degenerative Spinal Disease | For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months | 12-months curve type N | 0 Participants |
Secondary
Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.
The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months. The following were considered as signs of instrumentation instability: * Screw pullout * Screw loosening * Screw toggle
Time frame: Surgery to 12 months.
Population: 2 subjects completed the 12 month follow-up visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Degenerative Spinal Disease | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Stable Construct | 1 Participants |
| Degenerative Spinal Disease | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Unstable Construct | 0 Participants |
| Deformity | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Stable Construct | 1 Participants |
| Deformity | Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. | Unstable Construct | 0 Participants |
Secondary
Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.
The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays. The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (\<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as No fusion success. For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.
Time frame: Surgery to 12 months.
Population: 2 subjects who completed the 12 month follow-up visit were analyzed for fusion assessment with radiographic images.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Degenerative Spinal Disease | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Fusion success | 0 Participants |
| Degenerative Spinal Disease | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | No fusion success | 0 Participants |
| Degenerative Spinal Disease | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Unable to determine | 1 Participants |
| Deformity | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Fusion success | 0 Participants |
| Deformity | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | No fusion success | 0 Participants |
| Deformity | Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. | Unable to determine | 1 Participants |
Secondary
Rate of Intraoperative Cement Extravasation/Leakage. Patients
The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
Time frame: Surgery to 12 months.
Population: 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degenerative Spinal Disease | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Patients with cement extravasation | 3 participants |
| Degenerative Spinal Disease | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Patients with symptomatic extravasation | 0 participants |
| Deformity | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Patients with cement extravasation | 5 participants |
| Deformity | Rate of Intraoperative Cement Extravasation/Leakage. Patients | Patients with symptomatic extravasation | 0 participants |
Secondary
Rate of Intraoperative Cement Extravasation/Leakage. Screws
The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
Time frame: Surgery to 12 months.
Population: 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degenerative Spinal Disease | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Number of Cemented Fenestrated Screws | 39 Screws |
| Degenerative Spinal Disease | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Fenestrated Screws with cement extravasation | 3 Screws |
| Degenerative Spinal Disease | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Fenestrated screws with symptomatic cement extravasation | 0 Screws |
| Deformity | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Number of Cemented Fenestrated Screws | 97 Screws |
| Deformity | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Fenestrated Screws with cement extravasation | 8 Screws |
| Deformity | Rate of Intraoperative Cement Extravasation/Leakage. Screws | Fenestrated screws with symptomatic cement extravasation | 0 Screws |
Secondary
Rate of Neurological Success at 12-month Visit
Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced). Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).
Time frame: Baseline to 12 months.
Population: 21 subjects were assessed at Baseline,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Due to the premature termination of the study, the number of subjects who completed the 12 months follow-up visit was very low (N=2/21, 9.5%).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Motor Functions_Baseline | 5 score on a scale |
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Reflexes_Baseline | 2 score on a scale |
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Sensory Functions_Baseline | 3 score on a scale |
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Reflexes_12 Months | 2 score on a scale |
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Motor Functions_12 Months | 5 score on a scale |
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Straight Leg Raise_Baseline | 2 score on a scale |
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Sensory Functions_12 Months | 3 score on a scale |
| Degenerative Spinal Disease | Rate of Neurological Success at 12-month Visit | Straight Leg Raise_12 Months | 2 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Straight Leg Raise_12 Months | 2 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Motor Functions_Baseline | 5 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Motor Functions_12 Months | 5 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Sensory Functions_Baseline | 3 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Sensory Functions_12 Months | 3 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Reflexes_Baseline | 2 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Reflexes_12 Months | 2 score on a scale |
| Deformity | Rate of Neurological Success at 12-month Visit | Straight Leg Raise_Baseline | 2 score on a scale |
Secondary
Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery
When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery. Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.
Time frame: Surgery to 12 months.
Population: 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degenerative Spinal Disease | Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery | 0 Participants |
| Deformity | Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery | 1 Participants |