NCT04631133 LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
| NCT ID | NCT04631133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BACKBONE |
| Condition | Chronic Low-back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 136 participants |
| Start Date | 2019-04-17 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 136 participants in total. It began in 2019-04-17 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Vincent Pointillart
PRINCIPAL INVESTIGATOR
Pellegrin University Hospital Center
Frequently Asked Questions
Who can join the NCT04631133 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04631133 currently recruiting?
Yes, NCT04631133 is actively recruiting participants. Contact the research team at aat@backbone.pro for enrollment information.
Where is the NCT04631133 trial being conducted?
This trial is being conducted at Silkeborg, Denmark, Bordeaux, France, Lyon, France, Paris, France and 1 additional location.
Who is sponsoring the NCT04631133 clinical trial?
NCT04631133 is sponsored by BACKBONE. The principal investigator is Vincent Pointillart at Pellegrin University Hospital Center. The trial plans to enroll 136 participants.