ION 3D Facet Screw System: Observational study of subjects previously implanted with ION 3D Facet Screw System.
Study summary
The purpose of this observational, multi-center, ambispective, serial case study is to collect real-world patient outcomes that characterize the long-term safety and effectiveness of the SurGenTec ION 3D® Facet Screw System in a cervical spine and a lumbar spine application.
Eligibility
Sex
ALL
Min age
21 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Previously implanted intra-facet with one ION® Facet Screw placed per joint bilaterally at one or more contiguous levels of the cervical spine (C3-C7), or one or more contiguous levels of the lumbar spine (L3-S1),
* Must have supplemental fixation at the target level(s),
* Skeletally mature (minimum age of 21 years but not greater than 80 years),
* Be willing and able to comply with the study protocol requirements, and
* Be willing to sign the study-specific Informed Consent Document.
Exclusion Criteria:
* Implanted with the ION Facet Screw System at a spinal level that includes the thoracic spine (T1-T12),
* Unilateral fixation with the ION Fact Screw System,
* Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period,
* Significant metabolic bone disease (diagnosis of osteoporosis or osteomalacia),
* Currently taking medications that are known to potentially interfere with bone healing (e.g. chronic oral/systemic steroids),
* Pregnant or nursing female, or
* Incarcerated at the time of the required 12-month evaluation.
Primary outcome measure(s)
Rate of Quantitative Fusion — 12 Months Post-Op Defined as \<5 degrees of angulation and/or \<3mm translation as measured on dynamic flexion and extension radiographs
Rate of Stability of operative level(s) — 12 Months Post-Op Substantial motion defined as \>5 degrees angulation and/or \>3mm translation as measured on dynamic flexion and extension radiographs.
Rate of Qualitative Fusion — 12 Months Post-Op Bridging bone present external to the ION 3D facet screw device as observed on CT scan.
Incidence of Serious Adverse Events — 12 Months Post-Op Freedom from ION 3D facet screw device-related serious adverse events as adjudicate by an independent reviewer.
Incidence of Secondary Surgical Events — 12 Months Post-Op Secondary surgical events at the operative level(s) from intraoperative through ≥12-month evaluation timepoint.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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