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Enrolling By Invitation
NCT06720948
The ION Facet Screw System Ambispective Evaluation
Conditions: Intra-facet ION 3D Facet Screw System
Sex: All
Ages: 21 Years – 80 Years
Healthy volunteers: No
Enrollment: 50
Sponsor: SurGenTec LLC
Location: Orthopaedics Northeast Fort Wayne Indiana
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 Criteria
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.
Source: ClinicalTrials.gov (NCT06720948). StuddyBuddy aggregates publicly available trial information.