Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Bone Fusion With CT(Postoperative 6 Months)
研究概览
简要总结
Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using autogenous iliac bone graft is gold standard, however, it may lead to donor-site morbidities. Preventing these complications, some authors have tried to use alterative bone graft substitutes. Among these alternatives, Cervios ChronOs™ which is the polyetheretherketone (PEEK) cage with b-tricalcium phosphate (TCP) has become popular and shown good clinical results. However, b-TCP has only osteoconduction ability of three osteogenic properties.
Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized bone matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and osteoinduction, therefore this alternative is expected to show superior bone fusion capability to PEEK cage with b-TCP. However, there has been no comparison study between the PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate bone fusion rate between these cervical spine cages using postoperative computed tomography (CT)
详细描述
Biologically, graft material should be endowed with several basic properties. Several synthetic materials and graft substitutes have been developed to maximize fusion outcomes while avoiding complications of harvesting autograft. Mixture of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), have been widely utilized for bony regeneration. On the other hand, demineralized bone matrix (DBM) has been utilized as a graft substitute with mainly its osteoinductive ability. While HA and β-TCP have osteoinductive osteoconductive properties and DBM has osteoconductive osteoinductive properties, a graft material fully incorporating both properties has not been developed. We hypothesize that an interbody graft material equipped simultaneously with osteoinductivity and osteoconductivity would enhance fusion achievement; however, clinical trials with mixture materials within a PEEK cage in ACDF surgery have rarely been performed.
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
- •Clinical diagnosis of cervical HIVD, CSR, CSM or OPLL
- •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.
- •Below -3.5 T-score by DEXA bone densitometry
- •Patient with hemorrhagic diseases
- •Patient with malignancy
- •Patient who is not suitable for this study judged by principal investigator
结局指标
主要结局
Bone Fusion With CT(Postoperative 6 Months)
时间窗: 6 months after surgery(ACDF)
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).
次要结局
- VAS of Radiating Pain (Postoperative 6 Months)(at 6 months after surgery (ACDF))
- VAS of Neck Pain(Postoperative 6 Months)(at 6 months after surgery (ACDF))
研究者
Jin S. Yeom
Associate Professor
Seoul National University Hospital