RecruitingNCT04631133

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant

LISA Post Market Clinical Follow-Up Study:Post Marketing Prospective Documentation of Clinical Outcomes (Post-operative, Safety and Performance) After Lumbar Dynamic Stabilization Surgery With LISA Implant

Sponsor

BACKBONE

Enrollment

136 participants

Start Date

Apr 17, 2019

Study Type

OBSERVATIONAL

Conditions

Lumbar canal stenosis Chronic Low-back Pain Degenerative Disc Disease Herniated Disc

Summary

The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV (Pfirrmann MRI classification). "Post-market" means the device (i.e. the LISA implant) being used in this study has already obtained CE certification and is commercially available for use in the European market. The LISA device consists of 3 components: A PEEK interspinous spacer, a polyester band, and a titanium blocker. The spacer is positioned between two adjacent spinous processes, the band is belted around the spinous processes and through the spacer, and the blocker is used to lock the band inside the spacer. Medical Device manufacturers conduct "post-market" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. With these studies, the long-term safety as well as performance of their medical devices are assessed. This study, which is initiated and sponsored by BACKBONE (LISA designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the LISA implant for the treatment of lumbar degenerative disease and to evaluate the treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting long-term clinical data on patients who have received the LISA implant — a device placed in the spine during surgery to treat chronic low back pain caused by degenerative disc disease. Degenerative disc disease happens when the cushioning discs between the vertebrae in the spine wear down over time, causing pain and reduced mobility. The LISA implant is designed to preserve motion in the spine while relieving pain, as an alternative to fusion surgery. This is a post-market registry, meaning the device is already approved for use. Researchers want to track real-world outcomes over time in patients who have had the surgery, to better understand how well the implant performs and whether complications arise. Patients will be followed with regular check-ins and assessments. You may be eligible if: - You are skeletally mature and at least 18 years old - You have low back pain caused by degenerative disc disease graded II, III, or IV on Pfirrmann MRI classification - Conservative (non-surgical) treatment has failed after at least 6 months You may NOT be eligible if: - Your degenerative disc is at Stage V on Pfirrmann's classification - You have spondylolisthesis (vertebrae slipping out of alignment) - You have osteoporosis - Your back pain has no specific structural cause - You have Modic 2 or 3 changes on MRI, or L5/S1 segments affected - You have an active infection, severe mental illness, or bone metabolism disease - You are pregnant or breastfeeding - You are involved in workers' compensation, litigation, or disability claims Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELumbar Implant for Stiffness Augmentation (LISA)

The LISA Posterior Dynamic Stabilization System is intended to treat low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification).