DRKS00027163已完成不适用
Sponsor-initiated, prospective, mono center observational trial for evaluation of the Favo® S-TLIF cage used in spine surgery according to the intended purpose - Observational trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •The ability to read, understand and speak the local language fluently to ensure understanding of informed consent and protocol-specific assessments.
- •The surgical indication must be one or a combination of the following
- •+ Degenerative disc diseases
- •+ Spondylolisthesis (up to grade 1)
- •+ Segmental instabilities
- •+ Spinal canal stenosis
- •+ Neuroforaminal stenosis
- •+ Intraforal herniated disc
- •+ 1-2 Level OPs (L1-S1)
- •+ Age: = 18 years
排除标准
- •Absolute contraindications
- •+ Expected or documented allergy or intolerance to the materials (e.B. titanium)
- •+ Any case in which the chosen implants would be too large or too small, to achieve a successful result
- •+ Any patient in whom the use of the implant would conflict with anatomical structures
- •+ Lack of bony structures that make a good anchoring of the implants impossible (e.g. in fractures, tumors, osteoporosis or Infections).
- •Relative contraindications
- •+ patient's overweight (BMI > 35)
- •+ Fever or leukocytosis
- •+ Systemic diseases and metabolic disorders
- •+ One-sided diet, drug abuse, nicotine, alcohol or drug use
- •+ Physical activities associated with severe vibrations in which the implant is subjected to blows and/or excessive stress (e.B. heavy physical work, competitive sports, marathons, alpine skiing, jumping and team sports)
- •+ Patients who are mentally unable to understand and follow the doctor's instructions
- •+ Operations on pregnant women should be avoided as far as possible or require special care or procedures. This is at the discretion of the surgeon.
- •+ Any condition that could rule out the potential benefit of spinal implantation shall be clarified by the responsible physician. These can be: Tumors
- •+ A significant shift in the total blood count or other parameters.
- •+ The subject has anatomical or comorbid conditions or other medical, social or psychological conditions which, in the opinion of the investigator, increase the ability of the subject to participate in the clinical trial or to meet the follow-up requirements or affect the scientific soundness of the results of the clinical trial.
研究者
相似试验
尚未招募
不适用
Sponsor-initiated, prospective, monocentric, non-interventional clinical observational study to evaluate the VERTICALE® Cervical System in spine surgery use according to the intended purpose.M50.3M54M48M47M50Other cervical disc degenerationDorsalgiaOther spondylopathiesSpondylosisCervical disc disordersDRKS00028627Silony Medical GmbH43
尚未招募
不适用
Sponsor-initiated, prospective, monocentric, non-interventional clinical observational study (AWB) to evaluate the Transmaxx® ALIF Cage in spine surgery use according to the intended purpose.M51M43Other intervertebral disc disordersOther deforming dorsopathiesDRKS00031819Silony Medical GmbH43
进行中（未招募）
1 期
A prospective single centre, open label, pilot study to evaluate the safety of ICXP007 plus standard of care, for the treatment of lower extremity chronic, neuropathic diabetic foot ulcers - DFU IDiabetic foot ulcersEUCTR2006-000692-15-GBIntercytex15
已完成
不适用
A clinical study to compare the efficay and safety of Instavit oral spray for the Occassional SleeplessnessCTRI/2017/09/009834Instavit Ltd50
进行中（未招募）
4 期
To evaluate the Efficacy and Safety of Intra-Articular Hyaluronic Acid (HA)(Biovisc Ortho) in Patients with Knee Osteoarthritis (OA)CTRI/2018/01/011174VMMC and Safdarjung Hospital