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

Recruitingn/aAges 18 Years - anyAllBACKBONE
NCT04631133 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Skeletally mature patients Patient ≥18 years of age * Patients with low-back pain caused by degenerative lesions of grade II, III and IV (Pfirrmann MRI classification) * Failed conservative treatment for low back pain conducted for at least 6 months Exclusion Criteria: * Stage V degenerative disk lesions in Pfirrmann's MRI classification * Spondylolisthesis * Osteoporosis * Non-specific back pain * Modic 2 and Modic 3 changes * L5/S1 segments affected * Local or general infections that may compromise the surgical goals * Major local inflammatory phenomena * Pregnant and lactating Women * Immunosuppressive diseases * Bone immaturity * Severe mental illnesses * Bone metabolism diseases that may compromise the mechanical support expected from this type of implant * Patient with worker's compensation, under litigation or on disability benefits * Excessive physical activities * Patients deprived of their liberty in accordance with respective national regulations * Protected patients or patients not in a position to declare his or her consent in accordance with respective national regulations
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What it tests

  • Lumbar Implant for Stiffness Augmentation (LISA)
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Where

5 sites
Elective Surgery Center, Silkeborg Regional Hospital
Silkeborg, Denmark
Pellegrin University Hospital Center
Bordeaux, France
Saint-Charles Clinic
Lyon, France
Pitié-Salpêtrière University Hospital Center
Paris, France
Asklepios Stadtklinik, Bad Wildungen
Bad Wildungen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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