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Recruiting NCT04631133

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant

— Observational Chronic Low-back Pain Herniated Disc Degenerative Disc Disease Lumbar Canal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumbar Implant for Stiffness Augmentation (LISA).
Who it may be relevant to
Registry conditions: Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark, France, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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).

Primary outcome measures

  • LISA implant survival rate 2 years after surgery defined as successful LISA implantation without reoperation, revision, or removal/ ODI change between pre-operative assessment and 2 years follow-up (FU)/ 1ary endpoint will also be evaluated at 1-year FU [Time frame: 24-months post surgery; 12-months post surgery]
Secondary outcome measures (12)
  • LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal [Time frame: 3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery]
  • Duration of the surgery [Time frame: Perioperative]
  • Duration of the implant placement [Time frame: Perioperative]
  • Amount of blood loss [Time frame: Perioperative]
  • Scoring of the surgical technique assessed by a 14-items question [Time frame: Perioperative]
  • Number of hospitalization days [Time frame: 3-months post surgery]
  • Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar) [Time frame: 3-months post surgery]
  • Number of patients with reoperations/ revision or removal at the operative level or on adjacent levels relating to the device and not the pathology/ implant breakage (polyester band rupture) [Time frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery]
  • Number of patients with migration or rupture of any implant component (Polyester band loose)/ major unanticipated device related complications/ post-operative scapular pain/ recurrence of the initial symptoms/ degeneration of the adjacent segments [Time frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery]
  • Number of patients with superficial infection/ dural injury/ bone fracture or bone erosion anywhere implant is in contact with the anatomy/ Any other procedure or device related adverse events [Time frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery]
  • Oswestry Disability Index (ODI) to assess limitations of various activities of daily living. [Time frame: Pre-operative]
  • Change from baseline in Oswestry Disability Index at 3 months [Time frame: 3-months post surgery]

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Pellegrin University Hospital Center — Bordeaux
  • Saint-Charles Clinic — Lyon
  • Pitié-Salpêtrière University Hospital Center — Paris
Denmark · 1 center
  • Elective Surgery Center, Silkeborg Regional Hospital — Silkeborg
Germany · 1 center
  • Asklepios Stadtklinik, Bad Wildungen — Bad Wildungen

Identifiers

NCT: NCT04631133 · DHF-111-PMCF1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗