NCT02936739Unknown不适用
Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Neck disability index compared to baseline
研究概览
简要总结
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis
排除标准
- •Radiologic signs of extensive bone degeneration in the affected segment
- •Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software
- •Transversal spine cord lesion
- •Cervical myelopathy
- •Preceding surgery on the cervical spine
- •Traumatic lesions of the cervical spine
- •Radiographic instability in the affected segment: flexion / extension: shift sagittal plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation > 11º
- •signs of instability (Olisthesis) in another segment of the cervical spine
- •Active systemic infection
- •diseases of the rheumatic type and all autoimmune diseases
- •bone metabolic diseases (for example, Paget's disease)
- •skeletal metastases
- •infections in the cervical spine
- •Neurological seizure disorders or other serious neurological disease with risk of falls
- •Severe heart failure (NYHA III-IV)
- •Bleeding disorders or clopidogrel / coumarins - treatment
- •Systemic use of corticosteroids for more than a month in the last 12 months
- •Pregnancy
- •Legally incompetent patient
- •Lactation
- •Deformity, anomalies, not fully developed skeleton
- •Local tumor disease
- •Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy
- •Drug / drug or alcohol dependence
结局指标
主要结局
Change in Neck disability index compared to baseline
时间窗: 6 weeks, 3, 6, 12 and 24 months postoperative
次要结局
- Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline(6 weeks, 3, 6, 12 and 24 months postoperative)
- Change in EuroQOL (EQ-5D) compared to baseline(6 weeks, 3, 6, 12 and 24 months postoperative)
- Change in Core Outcome Measure Index (COMI) compared to baseline(6 weeks, 3, 6, 12 and 24 months postoperative)
- Change in flexion and extension radiographs compared to baseline(6 weeks, 3, 6 and 12 months postoperative)
- Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline(6 weeks, 3, 6 and 12 months postoperative)
- Change in consumption of analgetics compared to baseline(6 weeks, 3, 6, 12 and 24 months postoperative)
- Return to work(24 months postoperative)
- Mortality(24 months postoperative)
- Adverse effects(24 months postoperative)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (TM) After Anterior Cervical Discectomy for Cervical Disc ProlapseIntervertebral Disc DisplacementNCT02936765Technische Universität Dresden52
已完成
不适用
Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back PainChronic Low-back PainNCT05623735Eastern Mediterranean University74
已完成
不适用
Comparing Implant Stability Using Two Accepted Techniques for Implant SitesImplantNCT02096978Rutgers, The State University of New Jersey17
已完成
不适用
A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder PainShoulder PainNCT06467123University of Central Florida24
已完成
Unknown
Pulp regeneration for permanent mature teeth by application of normal scaffoldsecrotic single-rooted permanent straight teeth with mature rootsOral HealthISRCTN44531236Damascus University30