Cervicothoracic spine stabilization using PERLA® fixation system - A Post-Market Clinical Follow-Up Study - PERLA-PMCF

SPINEART SA0 个研究点目标入组 97 人开始时间: 2020年1月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Age: =18
•2. Patients presenting the following acute and chronic instabilities of the cervical spine (C1 to C7) and thethoracic spine from T1-T3, following pathologiesconfirmed clinically and radiographic assessment:
•? traumatic spinal fractures and/or traumatic dislocations
•? instability or deformity
•? failed previous fusions (e.g., pseudarthrosis)
•? tumours involving the cervical spine
•? degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or armpain of discogenic origin as confirmed by radiographic studies, and degenerative disease of thefacets with instability
•3. Psychosocially, mentally and physically able to fullycomply with the protocol including adhering to followup schedule and filling out forms.
•4. Written voluntary informed consent for use of their clinical, radiological and surgical data for scientific purposes related to safety and efficacy of the implanted device.

•1. Overt infection or distant foci of infections
•2. Local inflammation, with or without fever or leucocytosis
•3. Pregnancy
•4. Morbid obesity (BMI >40)
•5. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis
•6. Suspected or documented metal allergy or intolerance
•7. Anatomical abnormalities with potential risk on intraoperative neurological and/or vascular injury
•8. Severe comminuted fractures (such that segments may not be maintained in satisfactory proximate reduction)
•9. Displaced, non-reduced fractures with bone loss
•10. The presence of marked bone absorption or severe metabolic bone disease that could compromise the fixation achieved
•11. Poor prognosis for good wound healing (e.g., decubitus ulcer, uncontrolled diabetes, severe protein deficiency, and/or malnutrition)
•12. No need of bone graft or fusion
•13. Condition not described in the Instructions for use

发起方