NCT03302520已完成不适用
Comparison of Fusion Rate and Clinical Results Between Bioactive Glass Ceramics Spacer With PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, Randomized Controlled Non-inferiority Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Fusion rates
研究概览
简要总结
The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 30 and 80
- •patients who required one-level PLIF between L1 and S1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required PLIF due to grade I or II spondylolisthesis
- •those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form.
排除标准
- •osteoporosis patients with average T-scores of L1-L4 at <-3.0 in DEXA bone density tests
- •women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
- •patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
- •patients with abnormal blood potassium and phosphorus levels;
- •patients with liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease;
- •patients deemed to have less than 1-year life expectancy;
- •patients with mental retardation or whose parents or legal guardians were older or had mental disabilities;
- •other patients viewed as inappropriate by the staff
结局指标
主要结局
Fusion rates
时间窗: up to 5 year after operation
This is assessed by postoperative computed tomography at 1 year after surgery
次要结局
- EQ-5D(3, 6, and 12, months, and every year, up to 5 year after operation)
- Oswestry Disability Index (ODI)(3, 6, and 12, months, and every year, up to 5 year after operation)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(every year, up to 5 year after operation)
- Visual Analog Pain Scale (VAS)(3, 6, and 12, months, and every year, up to 5 year after operation)
- PainDETECT(3, 6, and 12, months, and every year, up to 5 year after operation)
- Fusion rates(every year, up to 5 year after operation)
研究者
Jin S. Yeom
Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Survival and Success of Two Different Filling TechniquesPeriapical DiseasesBioceramic SealersSurvival RateHealing RateNCT06252337University of Bologna80
Unknown
不适用
Study of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody FusionDegenerative Disk DiseaseNCT01439464BioAlpha Inc.86
终止
不适用
Emdogain and Straumann Bone Ceramic in Infrabony DefectsPeriodontitisNCT00906776Institut Straumann AG19
尚未招募
不适用
Evaluation of Premixed Verses Powder/Liquid Bioceramic MTA in Indirect Pulp Capping.Indirect Pulp CappingNCT05597553Cairo University24
已完成
4 期
Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene BearingsOsteonecrosisOsteoarthritisNCT01806766Ewha Womans University100