Actively Recruiting
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
Led by BACKBONE · Updated on 2022-07-21
136
Participants Needed
5
Research Sites
506 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Skeletally mature patients aged 18 years or older
- Low-back pain caused by degenerative lesions of grade II, III, or IV (Pfirrmann MRI classification)
- Failed conservative treatment for low-back pain for at least 6 months
You will not qualify if you...
- Stage V degenerative disk lesions in Pfirrmann's MRI classification
- Spondylolisthesis
- Osteoporosis
- Non-specific back pain
- Modic 2 and Modic 3 changes
- Affected L5/S1 segments
- Local or general infections that may compromise surgery
- Major local inflammatory conditions
- Pregnant or lactating women
- Immunosuppressive diseases
- Bone immaturity
- Severe mental illnesses
- Bone metabolism diseases affecting implant support
- Patients with worker's compensation, litigation, or disability benefits
- Excessive physical activity
- Patients deprived of liberty under national regulations
- Protected patients or those unable to consent under national regulations
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Elective Surgery Center, Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Actively Recruiting
2
Pellegrin University Hospital Center
Bordeaux, France, 33300
Actively Recruiting
3
Saint-Charles Clinic
Lyon, France, 69001
Actively Recruiting
4
Pitié-Salpêtrière University Hospital Center
Paris, France, 75013
Actively Recruiting
5
Asklepios Stadtklinik, Bad Wildungen
Bad Wildungen, Germany, D-34537
Actively Recruiting
Research Team
A
Aurélie Affret
CONTACT
N
Nazanine Sahami
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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