Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices

Investigate radiographic outcomes

Time frame: Enrollment

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.