JPRN-UMIN000026062已完成1 期
A Prospective Multi-centre, Randomised, Controlled Study to Evaluate the Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis by Interbody Fusion (L1 - S1). - Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis. ( Spine1 )
ovadip Biosciences Watson and Crick Hill Rue Granbonpre 11 B-1435 Mont-Saint-Guibert - Belgium0 个研究点目标入组 36 人开始时间: 2017年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •-Subject has known history of hypersensitivity or anaphylactic reaction to PEEK. -Due to medical or other reasons spine fusion cannot be delayed for up to 6 months. -Indications for spinal fusion other than symptomatic degenerative spondylolisthesis grade I and II (Meyerding Classification). -Subject has documented metabolic disease such as but not limited to severe osteoporosis, osteogenesis imperfect, or osteomalacia. -Subject with poorly controlled diabetes mellitus as assessed by glycohaemoglobin (HbA1c) > 8% (at least 2 values per year for last 2 years) -Subject is underweight, i.e. body mass index (BMI) <= to 18.5 or has a BMI of >= to 40, or >= to 35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes. -Overt or active local or systemic infection. -Subject has a history of previously attempted spinal fusion at the same level, or spine level immediately adjacent to the level to be operated. Decompressive surgery alone (laminectomy) is not an exclusion criterion. -Pregnant or breast-feeding woman. -Subject had an acute fracture of the spine within 6 months prior enrolment in the study. -Subject is currently taking chronically any medications that might affect bone metabolism or the quality of bone formation such as but not limited to bisphosphonates, steroids, methotrexate, anticoagulant therapies, immunosuppressants or immunotherapy. -Subject is positive for human immunodeficiency virus (HIV) 1 or 2, hepatitis B or C, human T-cell lymphotropic virus (HTLV) 1 or 2, or syphilis at screening. -Any clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the patient. -Subject is on chronic immunosuppressive therapy due to inflammatory or systemic disease. -Subject has a history of any autoimmune disease. -(other crietria apply)
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