Fenestrated Screw Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw Spinal System With Fenestrated Screw Cement When Used in the Treatment of Spinal Conditions in Subjects With Compromised Bone Quality

Conditions
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Degenerative Spinal Disease, Deformity of Spine

Intervention / Treatment
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* Device: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject must meet the following inclusion criteria to participate in this trial: 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) 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. 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. Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization and/or immobilization. Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement. At least 22 years old or greater at the time of informed consent. Is able to understand and willing to sign the Patient Informed Consent Form. 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: Has undergone stabilization and/or fusion procedure at the index or adjacent levels. Will undergo vertebroplasty or kyphoplasty procedure during surgery. Has been diagnosed with cauda equina syndrome. Has been previously diagnosed with clinically significant peripheral neuropathy. Has any degree of permanent neurologic deficit due to the presenting spinal disease (e.g. drop foot or gait deficit). Has obesity defined by BMI greater than or equal to 35kg/m2. 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) Has overt or active bacterial infection, local or systemic, and/or potential for bacteremia. Has a non-correctable spontaneous or therapeutic coagulation disorder or history of coagulation disorder associated with bleeding. Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) nonreactive to medical treatment. 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. Is pregnant or planning to become pregnant during the study duration. Is illiterate or considered vulnerable as per the Investigator's assessment (e.g., participants incapable of judgment, or participants under tutelage). Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenestrated Screw System<br> | Device: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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˚. | Baseline to 12 months | 
| 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. | Baseline, 3 months | 
| 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. | Baseline, 3, 12 months | 
| 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. | Baseline, 3, 12 months | 
| 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). | Baseline to 12 months. | 
| 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. | Surgery to 12 months. | 
| 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. | Surgery to 12 months. | 
| 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. | Surgery to 12 months. | 
| 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. | Surgery to 12 months. | 
| 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 | Surgery to 12 months. | 
| 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. | Surgery to 12 months. | 
| 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) | Baseline to 12 months | 
| 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) | Baseline to 12 months |