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

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

Inclusion Criteria3

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 Criteria17

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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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).