The ION Facet Screw System Ambispective Evaluation

Conditions

• Intra-facet ION 3D Facet Screw System

Eligibility Criteria

Sex

ALL

Age

21 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

First listed

Dec 6, 2024

Start date

Jan 31, 2025

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: 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)
• Arm: 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)

Primary Outcome Measure

Rate of Quantitative Fusion [ Time Frame: 12 Months Post-Op ]

Locations (3)

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