NL-OMON29150招募中不适用
Safety and clinical performance of the GEM-power Cable system in adult spinal deformity surgery
MaastrichtUMC+0 个研究点目标入组 14 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
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
入选标准
- •Signed and dated written informed consent prior to admission to the clinical investigation in accordance with good clinical practice (GCP) and local legislation
- •Male or non-pregnant females
- •> 50 years of age
- •Adult spinal deformity determined as an abnormality of spinal alignment in the axial, coronal or sagittal plane [1], amenable for surgical treatment
- •Planned surgical instrumented spinal fusion of > 4 levels (> 5 vertebrae)
- •Body Mass Index index (BMI) < 40 kg/m2
排除标准
- •Patients with metal allergy/intolerance
- •Patients with compromised anatomical integrity of the laminar arch or a previous spinal surgery which may have compromised the integrity of the laminar arch (i.e. laminectomy) at proximal construct levels.
- •Previous spinal deformity correction surgery
- •Patients with any form of kidney dysfunctioning
- •Female patients that are pregnant or plan to become pregnant
- •Patients unwilling to cooperate with the study protocol and follow up schedule
- •Patients judged by the surgeon mentally incapable to follow study requirements
- •Patients with neuromuscular or neuro-sensory deficit which would limit the ability to assess the performance of the device
- •Diagnosed with active malignancy
- •Active alcohol or drugs abuser as defined by currently undergoing treatment for this abuse or as judged by the surgeon is likely to interfere with protocol compliance
- •Known systemic or metabolic disorders leading to progressive bone deterioration except patients with osteoporosis with a T-score of minimal -3.5 (below -3.5 is exclusion)
- •Use of systemic corticosteroids within the last 3 months ( inhaled steroids are no reason for exclusion)
- •presence of an active or suspected infection
- •Chronic disease that compromises the immune system (e.g. known HIV or known hepatitis).
- •Uncontrolled diabetes mellitus as determined by treating physicians
- •Participation in an ongoing investigational drug or device trial that has not completed the follow-up period.
研究者
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