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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06720948). StuddyBuddy aggregates publicly available trial information.