A Long-term Follow-up Study to Evaluate the Efficacy and Safety for the Patients With Bioactive Glass-ceramic Intervertebral Spacer (Novomax) in Posterior Lumbar Interbody Fusion: Comparison With a Titanium Cage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Bone fusion with radiographs (X-ray)
研究概览
简要总结
This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.
详细描述
During one-level PLIF, bioactive glass-ceramic intervertebral spacer (Novomax) and titanium cage were inserted in the experimental group and control group, respectively. Bone fusion by simple radiography had angular deformity of less than 3 degrees and a potential of less than 3 mm in flexion extension radiographs, and thin-section CT (<2 mm) was used to determine the combination between the vertebral endplate and the autogenous bone or bioactive glass-ceramic intervertebral spacer (Novomax) in the cage without any gaps or the part connected to bony trabecula as fusion, and both groups will be compared.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[In Interventional Study]
- •Subjects who required 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
- •[In Long-term Follow-up Study]
- •Subjects who are treated with bioactive glass ceramic intervertebral spacer or titanium cage in one-level PLIF surgery
排除标准
- •[In Interventional Study]
- •Subjects with average T-scores of L1-L4 at <-3.0 in DEXA bone density tests
- •Subjects who are pregnant or breast-feeding
- •Subjects 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)
- •Subjects with abnormal blood potassium and phosphorus levels
- •Subjects who are considered not suitable for the study by significant disease(liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease)
- •Subjects who are not able to comply with the study requirements
- •Subjects who are considered not suitable for the study by the investigator
- •[In Long-term Follow-up Study]
- •Subjects who are not able to comply with the study requirements
- •Subjects who are considered not suitable for the study by the investigator
结局指标
主要结局
Bone fusion with radiographs (X-ray)
时间窗: for 36 months after surgery
Evaluation of bone fusion between bone substitutes and vertebral endplates with X-ray for 36 months(or more than 36 months) after PLIF surgery.
次要结局
- The Oswestry Disability Index(ODI) assessment(for 36 months after surgery)
- The SF(Short Form)-36 questionnaire assessment(for 36 months after surgery)
- Bone fusion with 3-dimensional computed tomography(CT)(for 36 months after surgery)
- VAS for target site(for 36 months after surgery)
- 1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability(for 36 months after surgery)