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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Elective Surgery Center, Silkeborg Regional Hospital
RECRUITING
Silkeborg
France
Pellegrin University Hospital Center
RECRUITING
Bordeaux
Saint-Charles Clinic
RECRUITING
Lyon
Pitié-Salpêtrière University Hospital Center
RECRUITING
Paris
Germany
Asklepios Stadtklinik, Bad Wildungen
RECRUITING
Bad Wildungen
Contact Information
Primary
Aurélie Affret
aat@backbone.pro
0033686114973
Backup
Nazanine Sahami
nsi@backbone.pro
0033646592539
Time Frame
Start Date: 2019-04-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 136
Treatments
Participants with low-back pain and degenerative lesions of grade II, III, IV (Pfirrmann MRI class)
Participants with low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification)
Sponsors
Leads: BACKBONE

This content was sourced from clinicaltrials.gov