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

Launched by BACKBONE · Nov 10, 2020

Keywords

ClinConnect Summary

The LISA Post Market Clinical Follow-Up Study is examining the long-term safety and effectiveness of the LISA implant, a device designed to help people suffering from chronic low-back pain due to certain degenerative conditions. This study is for adults aged 18 and older who have tried other treatments for at least six months without success. Eligible participants must have specific types of disc problems identified on MRI scans, but those with more severe issues, osteoporosis, or certain infections are not eligible.

If you choose to participate, you will be part of a study that helps researchers understand how well the LISA implant works over time. Your safety is a priority, and the study is designed to follow legal and ethical guidelines. Participants will receive the implant during surgery, and the study will track their progress to ensure that the device is performing as expected. This research is important because it helps improve treatments for back pain and ensures that implants like LISA are safe and effective for future patients.

Gender

ALL

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