Clinical trial NCT04631133: LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain
Herniated Disc
Degenerative Disc Disease
Lumbar Canal Stenosis
Keywords: Chronic Low-back Pain
Herniated Disc
Degenerative Disc Disease
Lumbar Canal Stenosis
Dynamic Stabilization Implants
Post-Market Clinical Follow-Up Study
Lead sponsor: BACKBONE
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must meet all inclusion criteria, and none of the exclusion criteria as described in the instructions for use of the LISA implant.

The Lumbar Implant for Stiffness Augmentation, LISA, treats low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification).

Brief summary: 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.


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

Primary outcomes:
measure: 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
timeFrame: 24-months post surgery; 12-months post surgery
Secondary outcomes:
measure: LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal
timeFrame: 3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery
measure: Duration of the surgery
timeFrame: Perioperative
measure: Duration of the implant placement
timeFrame: Perioperative
measure: Amount of blood loss
timeFrame: Perioperative
measure: Scoring of the surgical technique assessed by a 14-items question
timeFrame: Perioperative
measure: Number of hospitalization days
timeFrame: 3-months post surgery
measure: Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar)
timeFrame: 3-months post surgery
measure: 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)
timeFrame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
measure: 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
timeFrame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
measure: 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
timeFrame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
measure: Oswestry Disability Index (ODI) to assess limitations of various activities of daily living.
timeFrame: Pre-operative
measure: Change from baseline in Oswestry Disability Index at 3 months
timeFrame: 3-months post surgery
measure: Change from baseline in Oswestry Disability Index at 6 months
timeFrame: 6-months post surgery
measure: Change from baseline in Oswestry Disability Index at 48 months
timeFrame: 48-months post surgery
measure: Change from baseline in Oswestry Disability Index at 72 months
timeFrame: 72-months post surgery
measure: Visual Analogue Scale (VAS) to assess back pain
timeFrame: Pre-operative
measure: Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months
timeFrame: 3-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months
timeFrame: 6-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months
timeFrame: 12-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months
timeFrame: 24-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months
timeFrame: 48-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months
timeFrame: 72-months post surgery
measure: Visual Analogue Scale (VAS) to assess right leg pain
timeFrame: Pre-operative
measure: Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months
timeFrame: 3-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months
timeFrame: 6-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months
timeFrame: 12-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months
timeFrame: 24-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months
timeFrame: 48-months post surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months
timeFrame: 72-months post surgery
measure: Visual Analogue Scale (VAS) to assess left leg pain
timeFrame: Pre-operative
measure: Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months
timeFrame: 3-months post-surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months
timeFrame: 6-months post-surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months
timeFrame: 12-months post-surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months
timeFrame: 24-months post-surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months
timeFrame: 48-months post-surgery
measure: Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months
timeFrame: 72-months post-surgery
measure: Patient satisfaction with treatment assessed by a 4-items question
timeFrame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
measure: Patient's recommendation for treatment assessed by a 4-items question
timeFrame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
measure: Patient's opinion related to the treatment assessed by a 6-items question
timeFrame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
measure: Surgeon surgery outcome assessed by a 4-items question
timeFrame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
measure: Segmental joints condition assessed thanks to radiological results (if available)
timeFrame: Pre-operative
measure: Change from baseline in segmental joints condition at 3-months
timeFrame: 3-months post surgery
measure: Change from baseline in segmental joints condition at 6-months
timeFrame: 6-months post surgery
measure: Change from baseline in segmental joints condition at 12-months
timeFrame: 12-months post surgery
measure: Change from baseline in segmental joints condition at 24-months
timeFrame: 24-months post surgery
measure: Change from baseline in segmental joints condition at 48-months
timeFrame: 48-months post surgery
measure: Change from baseline in segmental joints condition at 72-months
timeFrame: 72-months post surgery
measure: Narrowness of the spinal canal assessed thanks to radiological results (if available)
timeFrame: Pre-operative
measure: Change from baseline in narrowness of the spinal canal at 3 months
timeFrame: 3-months post surgery
measure: Change from baseline in narrowness of the spinal canal at 6 months
timeFrame: 6-months post surgery
measure: Change from baseline in narrowness of the spinal canal at 12 months
timeFrame: 12-months post surgery
measure: Change from baseline in narrowness of the spinal canal at 24 months
timeFrame: 24-months post surgery
measure: Change from baseline in narrowness of the spinal canal at 48 months
timeFrame: 48-months post surgery
measure: Change from baseline in narrowness of the spinal canal at 72 months
timeFrame: 72-months post surgery
measure: Foraminal compression assessed thanks to radiological results (if available)
timeFrame: Pre-operative
measure: Change from baseline in foraminal compression at 3 months
timeFrame: 3-months post-surgery
measure: Change from baseline in foraminal compression at 6 months
timeFrame: 6-months post-surgery
measure: Change from baseline in foraminal compression at 12 months
timeFrame: 12-months post-surgery
measure: Change from baseline in foraminal compression at 24 months
timeFrame: 24-months post-surgery
measure: Change from baseline in foraminal compression at 48 months
timeFrame: 48-months post-surgery
measure: Change from baseline in foraminal compression at 72 months
timeFrame: 72-months post-surgery
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Elective Surgery Center, Silkeborg Regional Hospital
city: Bordeaux
country: France
facility: Pellegrin University Hospital Center
city: Lyon
country: France
facility: Saint-Charles Clinic
city: Paris
country: France
facility: Pitié-Salpêtrière University Hospital Center
city: Bad Wildungen
country: Germany
facility: Asklepios Stadtklinik, Bad Wildungen
Study officials:
affiliation: Pellegrin University Hospital Center
name: Vincent Pointillart
role: PRINCIPAL_INVESTIGATOR
References: