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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 27
- Locations
- 6
- Primary Endpoint
- Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/cm
- •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/m
- •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*.
Arms & Interventions
Fenestrated Screw System
Intervention: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement (Device)
Outcomes
Primary Outcomes
Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline
Time Frame: 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 Outcomes
- For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.(Baseline to 12 months)
- Rate of Intraoperative Cement Extravasation/Leakage. Patients(Surgery to 12 months.)
- For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.(Baseline to 12 months)
- Change in ODI From Baseline at 3 Months Visit(Baseline, 3 months)
- Rate of Neurological Success at 12-month Visit(Baseline 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(Surgery to 12 months.)
- Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.(Surgery to 12 months.)
- 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)
- Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline(Baseline, 3, 12 months)
- Rate of Intraoperative Cement Extravasation/Leakage. Screws(Surgery to 12 months.)
- 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)
- Device and/or Procedure Related Adverse Events Through 12 Months.(Surgery to 12 months.)
- Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.(Surgery to 12 months.)