Safety Study of a Spinal Implant for Lower Back Pain

Plain-English translation of NCT07834736 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated November 2026 · How we translate trials

What is this trial?

This trial is studying the Fortilink-TS Ti, a cage-shaped implant placed in the lower spine during fusion surgery. The study will follow about 50 patients for one year after surgery to make sure the implant is safe and works well for treating degenerative disc disease (wear and tear of the spine) and mild slippage of vertebrae.

Even though this implant has been used in patients since 2020, the manufacturer wants to gather more real-world information about how well it performs and any safety concerns in the specific group of patients it's designed for.

Do you qualify?

You likely qualify if…

you are willing to give informed consent and participate in the study
you have tried at least 6 months of non-operative treatment (like physical therapy or injections) without enough relief
you have been diagnosed with degenerative disc disease or mild vertebral slippage (grade 1 spondylolisthesis) in your lower spine
you are skeletally mature (your bones have finished growing)

You likely don't qualify if…

you have an active infection anywhere in your body or at the surgical site
you have severe osteoporosis (very weak bones) that could affect healing
you have a spinal tumor or cancer affecting your spine
you are unable to follow post-surgery restrictions, rehabilitation exercises, or attend follow-up appointments
you are pregnant

What participation looks like

You would receive standard spinal fusion surgery with the Fortilink-TS Ti implant at one of two participating hospitals. The study simply involves collecting information about your medical history before surgery, details from the surgery itself, and your recovery over one year. You'll attend the same follow-up visits and receive the same care as patients having this surgery outside the study—nothing extra or experimental.

AI-generated summary from trial data · Nov 14, 2026 · Not medical advice

Safety Study of a Spinal Implant for Lower Back Pain

What is this trial?

Do you qualify?

What participation looks like

Trial locations(2 sites)