The ION Facet Screw System Ambispective Evaluation
Enrolling by invitation
Conditions studied: Intra-facet ION 3D Facet Screw System
In brief
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.
Key facts
- Study ID
- NCT06720948
- Run by
- SurGenTec LLC
- People needed
- 50
- Starts
- 2025-01-31
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-21
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 tobacco use
- 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.
Where it is running
- Orthopaedics Northeast — Fort Wayne, Indiana, United States
- Neuroscience Specialists — Oklahoma City, Oklahoma, United States
- Shannon Clinic — San Angelo, Texas, United States
Full record on ClinicalTrials.gov
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