Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiological Assessment : Fusion Status
研究概览
简要总结
The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
详细描述
This is a prospective study with the intent to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. At the time a patient is scheduled for surgery, the patient's chart will be evaluated for inclusion/exclusion criteria. If a patient meets the criteria for the study, the study will be explained to the patient and consent obtained.
Investigators will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware) will be utilized.
Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.
Study Outcomes:
- Radiological assessment (cervical spine x-ray and if needed, computed tomography (CT) at 1 year follow up)of fusion as the primary endpoint
- Arthrodesis rates assessed using CT (1 year follow up, if needed) and Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays pre-operative (pre-op), post-operatively (post-op) 2~4 weeks (10~34 days post op), 3 months (83~97 days post-op), 6 months (173~187 days post-op) and 1 year post-op (351~379 days post op, primary data point outcome)
- Revision rates
- Outcome scores: Visual Analog Scale (VAS) and Neck Disability Index (NDI) pre-op, post-op 2~ 4weeks, 3 months, 6 months and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Scheduled 1 or 2-level ACDF spine surgery
- •The capacity to provide informed consent.
- •Subject has one or more of the following diagnoses:
- •Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- •Trauma (including fractures)
- •Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- •Pseudoarthrosis
- •Failed previous fusion
- •Decompression of the spinal cord following total or partial cervical vertebrectomy
- •Spondylolisthesis
- •Spinal stenosis
排除标准
- •Patients with any of the following conditions will be excluded, or if enrolled and found to be ineligible and do not fit the inclusion criteria, will be withdrawn from the study.
- •Patients with current or recent history of malignancy or infectious disease.
- •The inability to provide informed consent.
- •Subject has marked local inflammation
- •Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
- •Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices.
- •Subject has bone abnormalities preventing safe screw fixation.
- •Subject has any open wounds.
- •Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
- •Subject has a documented or suspected metal sensitivity.
- •Subject is pregnant.
- •Subject has anatomical structures or physiological performance that would interfere with implant utilization.
- •Subject has inadequate tissue coverage over the operative site.
- •Subject has other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
- •Note: The Aviator Anterior Cervical Plating System is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The surgeon must consider the levels of implantation, patient weight, patient activity level, and other patient conditions which may impact on the performance of the system.
研究组 & 干预措施
BIO4 treatment
Patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
干预措施: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). (Biological)
BIO4 treatment
Patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
干预措施: Aviator Anterior Cervical Plating System (Device)
结局指标
主要结局
Radiological Assessment : Fusion Status
时间窗: Post-op 1 year
This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say "Yes". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 "yes".
Arthrodesis Rates
时间窗: Post-op 1 year
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. We counted the number of patients who developed arthrodesis. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
次要结局
- VAS(Post-op 1 year)
- Arthrodesis Rates(Post-op 6 months)
- Revision Rates (if Any)(Post-op 1 year)
- NDI(Post-op 1 year)
- Revision Rates (if Any)(Post-op 2~4 weeks)
- Revision Rates (if Any)(Post-op 3 months)
- Revision Rates (if Any)(Post-op 6 months)
- VAS(Pre-op)
- VAS(Post-op 2 ~ 4 weeks)
- VAS(Post-op 3 months)
- VAS(Post-op 6 months)
- NDI(Pre-op)
- NDI(Post-op 2~4 weeks)
- NDI(Post-op 3 months)
- NDI(Post-op 6 months)
- Arthrodesis Rates(Pre-op)
- Arthrodesis Rates(Post-op 2~4 weeks)
- Arthrodesis Rates(Post-op 3 months)