A Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix* Device to treat Chronic Discogenic Low Back - GelStix Study

EOC Lugano0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Age between 18-66 years.
•- One or two levels of lumbar degenerative disc disease on magnetic resonance imaging (MRI) scan with Pfirrmann grade 2, 3 or 4.
•- Positive discography
•- Predominant persistent, nociceptive low back pain that worsens with axial loading and improves with recumbence of at least 12 weeks duration.
•- Failure to have symptoms resolved or reduced following at least 12 weeks conservative care (pain medication and/or physical therapy).
•- Annulus must be competent as determined by lumbar discography
•- Negative medial branches block results.
•- Patients presenting with a baseline level scores evaluated by NRS of at least 5/10.
•- Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation

•- Radiculopathy caused by nerve root compression.
•- Frank herniations, extruded or sequestered fragments, bulge/protrusions >3mm at any lumbar disc level.
•- Greater than grade 4 annular tear (Modified Dallas Grading) at any lumbar disc level.
•- Severe symptomatic central, foraminal or lateral recess stenosis, spondylolysis, spondylolisthesis, acute fractures, or ankylosing spondylitis at any lumbar disc level.
•- Coagulopathy or oral anticoagulant therapy (except low-dose acetylsalicylic acid) in conditions that do not allow for a temporary discontinuation.
•- Active infection, systemic or localized; any disease process or condition that may make the effect of the treatment difficult to evaluate (e.g. cancer, substance abuse, etc.)
•- Previous surgery at any lumbar disc level.
•- Disc height less than 5mm at the symptomatic level, or less than 50% of the highest lumbar disc
•- Presence of Schmorls nodes at the implanted level.
•- Females of childbearing age that are known to be pregnant or wishing to be pregnant during the study.
•- Psychological disorders or factors that may impact upon treatment outcomes or compliance (e.g. severe depressions).
•- Failure to understand informed consent or participation in any other clinical study.
•- BMI (Body Mass Index (kg/m2) of >= 35

发起方

EOC Lugano