The ION Facet Screw System Ambispective Evaluation (FixatION)

An Observational Multicenter Consecutive Case Study of Long-Term Safety and Effectiveness Outcomes of a Real-World Population

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intra-facet ION 3D Facet Screw System
• Intervention / Treatment: Device: ION 3D Facet Screw System

Detailed Description

The statistical analysis of the data obtained from this study will be performed using a validated statistical software program such as SPSS®. All tests will be performed at the 0.05 significance level, unless otherwise specified. Analysis will be based upon the treated population defined as all subjects that underwent standard of care surgical intervention with the SurGenTec ION 3D Facet Screw System that agreed to participate in this data collection initiative.

Data collected in this study will be documented using summary tables and subject data listings. Continuous variables will be summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum, and maximum, and a 95% confidence interval for the mean based on the t-distribution. Categorical variables will be summarized using frequencies, percentages, and 95% confidence intervals for the true proportions. Resultant of the observational study design, this evaluation is not powered to test a hypothesis. It is designed to yield supplemental long-term information in this real-world population.

The analysis will be stratified by lumbar and cervical patients. Additionally, each cohort will evaluate the following analysis populations:

Enrolled Population: This dataset will include all subjects who were screened and enrolled into the study.

Evaluable Population: This dataset will exclude subjects with ION 3D Facet Screw device improperly placed

To minimize the introduction of bias into this observational low risk evaluation, the following measures will be observed:

• Complete and accurate prespecified data shall be obtained,
• All cervical and all lumbar patients at a study site that were previously implanted with the ION 3D Facet Screw System will be reviewed for possible study inclusion (all-comers study design),
• All participants will be enrolled under the same study entrance criteria,
• All participants shall follow the same prospectively designed study protocol,
• Serious Adverse Event adjudication will be performed by independent blinded reviewer, and
• Radiographic measurements and CT assessments will be performed by blinded independent core lab.

In consideration of the retrospective nature of this investigation coupled with a possible 1-time prospective evaluation, data monitoring will not be performed. However, data edits and database checks will be built into the EDC system to minimize the potential for data entry errors. Further, TSN, as the entity responsible for overall study conduct/management, will review all data entered and ensure appropriate source documentation is available to support data extraction/collection.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Orthopaedics NorthEast
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Neuroscience Specialists
  • Texas
    • San Angelo, Texas, United States, 76903
      • Shannon Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Observational study of subjects previously implanted with 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; Observational study of subjects previously implanted with ION 3D Facet Screw System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SurGenTec LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: fixation; ION
• Other Study ID Numbers: TSN-2024-001; ION Facet RWE Study (Other Identifier: SurGenTec)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No