NCT07017634招募中3 期
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
CGBio Inc.5 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2026年6月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 5
- 主要终点
- Overall Success
研究概览
简要总结
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.
- •Has a history of failure conservative treatment (e.g. bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinal injections) for at least 6 months
- •Has preoperative Oswestry Disability Index score ≥ 40/100 at baseline
- •Male or Female, 21-80 years of age and skeletally mature at the time of surgery
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
- •Signed informed consent
排除标准
- •Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
- •Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);
- •Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
- •Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
- •Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
- •Lactating, pregnant or interested in becoming pregnant in the next 3 years;
- •Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.
- •Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.
研究组 & 干预措施
Novosis Putty
Experimental
干预措施: Novosis Putty (Device)
Standard of Care
Active Comparator
干预措施: Standard of Care (Other)
结局指标
主要结局
Overall Success
时间窗: 24 months after surgery
Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event
次要结局
- Overall Success(6 and 12 months after surgery)
- ODI score(6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery)
- VAS score(6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery)
- SF-12 score(6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery)
- Fusion Success(12 months after surgery)
- Fusion Success(6 and 24 months after surgery)
- Time to Fusion Success(From surgery to 60 months after surgery)
- Time to First SSI(From surgery to 60 months after surgery)
- Treatment satisfaction(6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery)
- Intraoperative variables(intraoperative)
研究者
研究点 (5)
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