Fusion Status of Machined Allograft Versus Iliac Crest Allograft in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Improved participant reported outcome measures (PROMs)-3
研究概览
简要总结
Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial.
详细描述
Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and diminish the amount of intervertebral graft resorption when compared to off-the-shelf machined allografts
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients 18 years of age or older
- •preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.
排除标准
- •patients undergoing a revision cervical procedure
- •current smokers
- •patient with surgical indications of tumor, infection, or trauma
研究组 & 干预措施
Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft
Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft
干预措施: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft (Procedure)
Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft
Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft
干预措施: Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft (Procedure)
结局指标
主要结局
Improved participant reported outcome measures (PROMs)-3
时间窗: 2 years
Investigators will ask participants to complete the modified Japanese Orthopaedic Association (mJOA) score) at 3 months, 6 months, 12 months, and 24 months following surgery
Fusion status after surgery
时间窗: 2 years
Fusion status will be assessed using Postoperative x-rays (AP, lateral, flexion, extension) which will be taken at 3 months, 6 months, 12 months, and 24 months following surgery
Improved participant reported outcome measures (PROMs)-1
时间窗: 2 years
Investigators will ask participants to complete the Short Form-12 survey (SF-12) at 3 months, 6 months, 12 months, and 24 months following surgery
Improved participant reported outcome measures (PROMs)-2
时间窗: 2 years
Investigators will ask participants to complete the Visual Analog Score (VAS) for Neck and Arm, Neck Disability Index (NDI), at 3 months, 6 months, 12 months, and 24 months following surgery
次要结局
未报告次要终点