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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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).

Первичные конечные точки

• 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 [Срок оценки: 24-months post surgery; 12-months post surgery]

Вторичные конечные точки (12)

• LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal [Срок оценки: 3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery]
• Duration of the surgery [Срок оценки: Perioperative]
• Duration of the implant placement [Срок оценки: Perioperative]
• Amount of blood loss [Срок оценки: Perioperative]
• Scoring of the surgical technique assessed by a 14-items question [Срок оценки: Perioperative]
• Number of hospitalization days [Срок оценки: 3-months post surgery]
• Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Pre-operative]
• Change from baseline in Oswestry Disability Index at 3 months [Срок оценки: 3-months post surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 3 центра

• Pellegrin University Hospital Center — Bordeaux
• Saint-Charles Clinic — Lyon
• Pitié-Salpêtrière University Hospital Center — Paris

Дания · 1 центр

• Elective Surgery Center, Silkeborg Regional Hospital — Silkeborg

Германия · 1 центр

• Asklepios Stadtklinik, Bad Wildungen — Bad Wildungen

Идентификаторы

NCT: NCT04631133 · DHF-111-PMCF1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗