DRKS00009238尚未招募未知
Prospective randomized trial regarding the use of PEEK-Rods for stabilization in lumbar circumferential fusion
Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus Rudolf Elle gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena0 个研究点目标入组 100 人开始时间: 2015年8月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Patients with persistent lumbar, lumbosacral and/or non-radicular / radicular complaints, after failed conservative treatment of a period of at least 6 months will be included in the study. At the same time, in MRI a single-level lumbar osteochonditis Modic Type = 1 based on an idiopathic intervertebral disc degeneration Pfirrmann = III and/or a facet joint degeneration Grade 3 or 4 according to Fujiwara has to be present. Additional spinal or neuroforaminal stenoses as well as nucleus prolapses at the index segment do not represent contraindications. Degenerative spondylolistheses of the index segment up to Meyerding I as well as previous sequestrektomies or selective inter laminar decompression surgeries at the index segment do also not lead to exclusion. Every patient has to sign an agreement form with study
排除标准
- •Patients with symptomatic segment degeneration of more than 1 lumbar segment as well as patients who had undergone spinal surgeries different from the described under inclusion criteria will be excluded from the study.
- •Further exclusion criteria are spondylolistheses > Meyerding I or lumbar scoliosis Cobb-angle =10°. Patients with chronic nikotine-, alcohol- or drug abusus, a known allergy against (parts of) the implants, a „Body-Mass-Index (BMI) >30 kg/m2, as well as pregnant patients will be excluded from the study. Additionally, clinical, blood parameters or radiological signs of a renal- and liver disease, malignant tumours, chronic medication with corticoids or bone density increasing antiosteoporotic substances, presence of a chronic pain / somatization disorder (> Stadium I according to Gerbershagen), epilepsy or further diseases or reasons leading to recurrent falls lead to exclusion. Beside this, patients with the need for screw augmentation with bone cement as well as patients with the need of surgical revision due to screw misplacement or lateral screw misplacement > grade 2 (according to Mirza) in postoperative CT weill be excluded because of its negative influence on the grade of stability of the segment fixation.
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