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.
Study Type
OBSERVATIONAL
Enrollment
136
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).
Elective Surgery Center, Silkeborg Regional Hospital
Silkeborg, Denmark
RECRUITINGPellegrin University Hospital Center
Bordeaux, France
RECRUITINGSaint-Charles Clinic
Lyon, France
RECRUITINGPitié-Salpêtrière University Hospital Center
Paris, France
RECRUITINGAsklepios Stadtklinik, Bad Wildungen
Bad Wildungen, Germany
RECRUITINGLISA 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
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
14 steps of the surgical technique are rated from 0 to 7; 0 being considered as very easy and 7 being considered as very difficult
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
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Time frame: 3-months post surgery
Change from baseline in Oswestry Disability Index at 6 months
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Time frame: 6-months post surgery
Change from baseline in Oswestry Disability Index at 48 months
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Time frame: 48-months post surgery
Change from baseline in Oswestry Disability Index at 72 months
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Time frame: 72-months post surgery
Visual Analogue Scale (VAS) to assess back pain
Patients rate their back pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Time frame: Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months
Time frame: 3-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months
Time frame: 6-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months
Time frame: 12-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months
Time frame: 24-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months
Time frame: 48-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months
Time frame: 72-months post surgery
Visual Analogue Scale (VAS) to assess right leg pain
Patients rate their right leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Time frame: Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months
Time frame: 3-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months
Time frame: 6-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months
Time frame: 12-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months
Time frame: 24-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months
Time frame: 48-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months
Time frame: 72-months post surgery
Visual Analogue Scale (VAS) to assess left leg pain
Patients rate their left leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Time frame: Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months
Time frame: 3-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months
Time frame: 6-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months
Time frame: 12-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months
Time frame: 24-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months
Time frame: 48-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months
Time frame: 72-months post-surgery
Patient satisfaction with treatment assessed by a 4-items question
Patients rate their satisfaction with treatment choosing one of the following options: Very satisfied/Somewhat satisfied/Somewhat dissatisfied/Very Dissatisfied
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
Patient's recommendation for treatment assessed by a 4-items question
Patient rate wether they would recommend the same treatment to a friend with the same condition, choosing one of the following options: Definitely YES/Probably YES/ Probably NO/ Definitely NOT
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
Patient's opinion related to the treatment assessed by a 6-items question
Patient rate how effective was the treatment in eliminating the symptoms choosing one of the following options: "very effective, relieved all the symptoms", "moderately effective", "somewhat effective", "somewhat ineffective", "moderately ineffective", "very ineffective, did not relieve or lessen the symptoms"
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
Surgeon surgery outcome assessed by a 4-items question
Surgeons rate the result of the surgery, choosing one of the following options: Excellent; Good; Fair; Poor
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
Segmental joints condition assessed thanks to radiological results (if available)
Time frame: Pre-operative
Change from baseline in segmental joints condition at 3-months
Segmental joints condition are assessed thanks to radiological results (if available)
Time frame: 3-months post surgery
Change from baseline in segmental joints condition at 6-months
Segmental joints condition are assessed thanks to radiological results (if available)
Time frame: 6-months post surgery
Change from baseline in segmental joints condition at 12-months
Segmental joints condition are assessed thanks to radiological results (if available)
Time frame: 12-months post surgery
Change from baseline in segmental joints condition at 24-months
Segmental joints condition are assessed thanks to radiological results (if available)
Time frame: 24-months post surgery
Change from baseline in segmental joints condition at 48-months
Segmental joints condition are assessed thanks to radiological results (if available)
Time frame: 48-months post surgery
Change from baseline in segmental joints condition at 72-months
Segmental joints condition are assessed thanks to radiological results (if available)
Time frame: 72-months post surgery
Narrowness of the spinal canal assessed thanks to radiological results (if available)
Time frame: Pre-operative
Change from baseline in narrowness of the spinal canal at 3 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Time frame: 3-months post surgery
Change from baseline in narrowness of the spinal canal at 6 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Time frame: 6-months post surgery
Change from baseline in narrowness of the spinal canal at 12 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Time frame: 12-months post surgery
Change from baseline in narrowness of the spinal canal at 24 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Time frame: 24-months post surgery
Change from baseline in narrowness of the spinal canal at 48 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Time frame: 48-months post surgery
Change from baseline in narrowness of the spinal canal at 72 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Time frame: 72-months post surgery
Foraminal compression assessed thanks to radiological results (if available)
Time frame: Pre-operative
Change from baseline in foraminal compression at 3 months
Foraminal compression is assessed thanks to radiological results (if available)
Time frame: 3-months post-surgery
Change from baseline in foraminal compression at 6 months
Foraminal compression is assessed thanks to radiological results (if available)
Time frame: 6-months post-surgery
Change from baseline in foraminal compression at 12 months
Foraminal compression is assessed thanks to radiological results (if available)
Time frame: 12-months post-surgery
Change from baseline in foraminal compression at 24 months
Foraminal compression is assessed thanks to radiological results (if available)
Time frame: 24-months post-surgery
Change from baseline in foraminal compression at 48 months
Foraminal compression is assessed thanks to radiological results (if available)
Time frame: 48-months post-surgery
Change from baseline in foraminal compression at 72 months
Foraminal compression is assessed thanks to radiological results (if available)
Time frame: 72-months post-surgery
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