The ION Facet Screw System Ambispective Evaluation

NCT06720948 | Enrolling By Invitation FDA Device

• 2 other identifiers: TSN-2024-001ION Facet RWE Study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Intra-facet ION 3D Facet Screw System

Keywords

ION; fixation

Outcome Measures

Primary Outcomes (5)

• Rate of Quantitative Fusion

  Defined as \<5 degrees of angulation and/or \<3mm translation as measured on dynamic flexion and extension radiographs

  12 Months Post-Op

• Rate of Stability of operative level(s)

  Substantial motion defined as \>5 degrees angulation and/or \>3mm translation as measured on dynamic flexion and extension radiographs.

  12 Months Post-Op

• Rate of Qualitative Fusion

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

  12 Months Post-Op

• Incidence of Serious Adverse Events

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

  12 Months Post-Op

• Incidence of Secondary Surgical Events

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

  12 Months Post-Op

Study Arms (2)

Cervical

Previously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the cervical spine (C3-C7)

Device: ION 3D Facet Screw System

Lumbar

Previously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the lumbar spine (L3-S1)

Device: ION 3D Facet Screw System

Interventions

ION 3D Facet Screw System DEVICE

Observational study of subjects previously implanted with ION 3D Facet Screw System.

Cervical; Lumbar

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients that have previously undergone a cervical or lumbar facet fusion with the ION® Facet Screw System (IFSS) * Patients must be a minimum of one year postoperative

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 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.

Sponsors & Collaborators

• SurGenTec LLC: lead

Study Sites (3)

Orthopaedics Northeast

Fort Wayne, Indiana, 46825, United States

Location

Neuroscience Specialists

Oklahoma City, Oklahoma, 73134, United States

Location

Shannon Clinic

San Angelo, Texas, 76903, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (3)