LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
Recruiting
Observational Study
Chronic Low-back Pain
Herniated Disc
Degenerative Disc Disease
Lumbar Canal Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 136 (estimated)
- Sponsor
- BACKBONE · Industry
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About This Trial
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 availabl…
Trial Locations
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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:
* Sta…
Contacts