LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
NCT ID: NCT04631133
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
136 participants
OBSERVATIONAL
2019-04-17
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
Lumbar 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).
Interventions
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Lumbar 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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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BACKBONE
INDUSTRY
Responsible Party
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Principal Investigators
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Vincent Pointillart
Role: PRINCIPAL_INVESTIGATOR
Pellegrin University Hospital Center
Locations
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Elective Surgery Center, Silkeborg Regional Hospital
Silkeborg, , Denmark
Pellegrin University Hospital Center
Bordeaux, , France
Saint-Charles Clinic
Lyon, , France
Pitié-Salpêtrière University Hospital Center
Paris, , France
Asklepios Stadtklinik, Bad Wildungen
Bad Wildungen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DHF-111-PMCF1
Identifier Type: -
Identifier Source: org_study_id
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