Prospective Study on Clinical and Radiological Results With Ennovate® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Aesculap AG
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Leg pain
研究概览
简要总结
The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results.
详细描述
Adult Isthmic spondylolisthesis, which is associated with "spondylolysis," is defined as an osseous discontinuity of the vertebral arch at the isthmus (the pars interarticularis), which usually occurs in the fifth lumbar vertebra. The prevalence of isthmic spondylosis is proposed to be about 6% to 26% in different studies. The European Spine Tango registry found 15%. It is proposed to affect more men than women. Conservative treatments including braces, physical therapy, and medication are shown to be effective for some patients; however, surgical treatments are mainly the final effective treatment. There are several different options for surgery among which posterolateral fusion (PLF) is considered as the method of choice. It is shown that PLF is more effective than conservative treatments such as exercise. The fusion helps to fix the motion of the affected segment and therefore, might lead to pain reduction. Decompression, supplemental instrumentation, and supplemental anterior column support are also considered for treatment. These treatment strategies can be used separately or in any combination; however, studies trying to compare separate treatments with a combination of them have led to inconsistent results.
Supplementary pedicle screws might be added to fusion methods for fixation and it is proposed that they have the ability to correct the deformity, reduce the listhesis, and increase the fusion rates, although a majority of the studies comparing instrumented PLF and noninstrumented PLF could not show the superiority of instrumented approaches. The literature has been reviewed in 2000 already, and the method has already been proved to be "practical, safe, and effective" for various spinal indications. Other authors found a better result for isthmic spondylolisthesis patients with posterior lumbar interbody Fusion (PLIF), vs. PLF, especially for high grade isthmic spondylolisthesis.
The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation also in the long-term.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic single-level IS (L4-S1), (VAS > 30mm, treated conservatively for a minimum of 6 months)
- •Isthmic Spondylolisthesis Meyerding grade I and II
- •Signed Informed Consent of the patient regarding the participation in this study
排除标准
- •Multilevel IS
- •Severe degenerative changes of cranial adjacent level (disc height of <50% of the next healthy segment,
- •Previous lumbar spine surgery except microdiscectomy or micro- decompression of the index level
- •Patients psychically or mentally not able to give or refuse consent
- •Patients psychically or mentally not able to answer the questions regarding their health status and quality of life
- •Pregnancy (current or planned)
- •Systemic or local infection
- •Chemotherapy or radiation ongoing
- •Desire of early retirement (running pension request)
- •All contraindications as listed in the instructions for use
结局指标
主要结局
Leg pain
时间窗: 1 year
Leg Pain measured by Visual analogue scale (VAS) after 1 year follow-up: measured by Visual Analogue Scale: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
次要结局
- Leg Pain(Preoperative, 3 months, 6 months)
- Back Pain(Preoperative, 3 months, 6 months, 1 year)
- Functional Disability(Preoperative, 3 months, 6 months, 1 year)
- Patient satisfaction(3 months, 6 months, 1 year)
- Loss of Reduction of the Reposition [degree](3 months, 6 months, 1 year)
- Clinical Complications(intraoperative, 3 months, 6 months, 1 year)
- Fusion status(3 months, 6 months, 1 year)
- Radiographically assessed complications(3 months, 6 months, 1 year)
- Range of Motion(3 months, 6 months, 1 year)
- Quality of Life(preoperative, 3 months, 6 months, 1 year)