LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
RecruitingNCT04631133
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Chronic Low-back Pain
- Herniated Disc
- Degenerative Disc Disease
- Lumbar Canal Stenosis
- Interventions
- Device: Lumbar Implant for Stiffness Augmentation (LISA)
- Sponsor
- BACKBONE
- Start date
- 2019-04-17
- Primary completion
- 2024-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark, France, Germany
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04631133