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NCT06720948

The ION Facet Screw System Ambispective Evaluation

Enrolling by Invitation
Not specifiedAges 21–80Observational
SurGenTec LLC
~50 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:ION 3D Facet Screw System

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Quantitative Fusion
Measured over 12 Months Post-Op
+4 more outcomes measured

Conditions

Intra-facet ION 3D Facet Screw System

Explore related trials

Spinal Disorders

Where it's being run

3 sites across 3 states
Indiana1
Oklahoma1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Rate of Quantitative Fusion12 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 Fusion12 Months Post-Op

    Bridging bone present external to the ION 3D facet screw device as observed on CT scan.

  • Incidence of Serious Adverse Events12 Months Post-Op

    Freedom from ION 3D facet screw device-related serious adverse events as adjudicate by an independent reviewer.

  • Incidence of Secondary Surgical Events12 Months Post-Op

    Secondary surgical events at the operative level(s) from intraoperative through ≥12-month evaluation timepoint.