Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices

The primary endpoints include the rate of fusion, and the rate of complications or reoperations.

Fusion Scale:1) Radiographically evaluate the rate of fusion, as determined by a panel of independent radiologists per the below fusion assessment metrics: Lumbar fusion grading scale (Minuteman G5): 1- Definitely fused 2- Probably fused 3- Probably not fused 4- Definitely not fused;

Sacroiliac fusion assessment (Liberty, Patriot):

Device(s) will be evaluated for (i) the presence of bridging bone from ilium to sacrum; and (ii) any evidence of migration or loosening

Additionally, if Minuteman G5 subjects have an interbody fusion device, interbody fusion will be assessed using the Bridwell scale:

1- Definite fusion 2- Probable fusion 3- Intermediate fusion/possible motion 4- Pseudoarthrosis/no bony connection

• Pain (Overall, Back and Leg) using NRS/numeric rating scale Overall pain, as well as back pain when standing/walking and leg pain when standing will be assessed using a numeric rating scale (NRS). The NRS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.

Oswestry Disability Index (ODI) ODI is a self-reported questionnaire widely used to track changes in a patient's condition over time and evaluate the effectiveness of treatments for low back pain. The ODI consists of 10 sections, each addressing a specific aspect of daily functioning. A higher score indicates greater disability. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed bound.

The Patient Global Impression of Change (PGIC) PGIC is a standardized tool designed to assess a patient's self-reported perception of improvement or worsening in their health status over time. The PGIC consists of 1 question, using a 1 to 7 scale: 1-Very Much Improved to 7-Very much Worse.

Subject Satisfaction Survey Subject Satisfaction Survey is made up of 8 questions designed to assess a patient's self-reported satisfaction or dissatisfaction on a Likert scale. The Likert scale consists of 8 questions individually scored on a 1 to 5 scale: With lower scores indicating higher satisfaction and higher scores indicating greater dissatisfaction.