NCT02425514已完成不适用
Evaluation of Bone Union Following Anterior Cervical Fusion Using a Bioactive Glass-Ceramic Spacer (NovoMax™): Comparison With a PEEK Cage Filled With β-Tricalcium Phosphate (Cervios ChronOs™)
BioAlpha Inc.2 个研究点 分布在 2 个国家目标入组 76 人开始时间: 2015年5月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient who is expected to receive anterior cervical discectomy and fusion operation.
- •Volunteer for this study with written consent.
排除标准
- •Patient with cervical spine fracture, infection and malignant tumor
- •Below -3.5 T-score by DEXA bone densitometry
- •Patient who is not suitable for this study judged by principal investigator
结局指标
主要结局
Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
时间窗: at 6 months after surgery (ACDF)
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (ACDF).
次要结局
- VAS of Neck Pain(Post operative 6 Months)(at 6 months after surgery (ACDF))
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular CarcinomaHepatocellular Carcinoma Stage IIINCT04961138Second Affiliated Hospital, School of Medicine, Zhejiang University164
招募中
1 期
A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent GlioblastomaRecurrent GlioblastomaNCT06097975Universitair Ziekenhuis Brussel18
尚未招募
2 期
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal CancerLocally Advanced Rectal CancerNCT06304987Beijing Friendship Hospital50
Unknown
2 期
Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical StudyGastroesophageal Junction AdenocarcinomaNCT03368131Hebei Medical University48
进行中（未招募）
2 期
Neoadjuvant/Adjuvant Pembrolizumab Plus ChemotherapyNon Small Cell Lung CancerNeoadjuvant TherapyImmune Checkpoint InhibitorNCT05383716Peking Union Medical College Hospital80