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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lumbar Canal Stenosis, Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease

Intervention / Treatment
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* Device: Lumbar Implant for Stiffness Augmentation (LISA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with low-back pain and degenerative lesions of grade II, III, IV (Pfirrmann MRI class)<br>Participants with low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification) | Device: Lumbar Implant for Stiffness Augmentation (LISA)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 24-months post surgery; 12-months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal |  | 3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery | 
| Duration of the surgery |  | Perioperative | 
| Duration of the implant placement |  | Perioperative | 
| Amount of blood loss |  | 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 | Perioperative | 
| Number of hospitalization days |  | 3-months post surgery | 
| Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar) |  | 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) |  | 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 |  | 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 |  | 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. |  | 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. | 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. | 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. | 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. | 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 | Pre-operative | 
| Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months |  | 3-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months |  | 6-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months |  | 12-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months |  | 24-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months |  | 48-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months |  | 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 | Pre-operative | 
| Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months |  | 3-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months |  | 6-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months |  | 12-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months |  | 24-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months |  | 48-months post surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months |  | 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 | Pre-operative | 
| Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months |  | 3-months post-surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months |  | 6-months post-surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months |  | 12-months post-surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months |  | 24-months post-surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months |  | 48-months post-surgery | 
| Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months |  | 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 | 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 | 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 | 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 | 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) |  | Pre-operative | 
| Change from baseline in segmental joints condition at 3-months | Segmental joints condition are assessed thanks to radiological results (if available) | 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) | 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) | 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) | 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) | 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) | 72-months post surgery | 
| Narrowness of the spinal canal assessed thanks to radiological results (if available) |  | 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) | 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) | 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) | 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) | 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) | 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) | 72-months post surgery | 
| Foraminal compression assessed thanks to radiological results (if available) |  | Pre-operative | 
| Change from baseline in foraminal compression at 3 months | Foraminal compression is assessed thanks to radiological results (if available) | 3-months post-surgery | 
| Change from baseline in foraminal compression at 6 months | Foraminal compression is assessed thanks to radiological results (if available) | 6-months post-surgery | 
| Change from baseline in foraminal compression at 12 months | Foraminal compression is assessed thanks to radiological results (if available) | 12-months post-surgery | 
| Change from baseline in foraminal compression at 24 months | Foraminal compression is assessed thanks to radiological results (if available) | 24-months post-surgery | 
| Change from baseline in foraminal compression at 48 months | Foraminal compression is assessed thanks to radiological results (if available) | 48-months post-surgery | 
| Change from baseline in foraminal compression at 72 months | Foraminal compression is assessed thanks to radiological results (if available) | 72-months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis, Dynamic Stabilization Implants, Post-Market Clinical Follow-Up Study