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

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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