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).
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. The null hypothesis is that in ACDF model, the clinical and radiographic outcomes of utilizing BIO4 bone matrix with Bio AVS Cervical Allograft are equivalent to historical high level published data of similar product (Data reported in Meta-analysis ACDF obtained from FDA disc arthroplasty trials).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The study 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). 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.
The study 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). 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.
Seton Spine and Scoliosis Center
Austin, Texas, United States
Radiological Assessment : Fusion Status
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".
Time frame: Post-op 1 year
Arthrodesis Rates
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.
Time frame: Post-op 1 year
Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
Time frame: Post-op 2~4 weeks
Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
Time frame: Post-op 3 months
Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
Time frame: Post-op 6 months
Revision Rates (if Any)
As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery
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Time frame: Post-op 1 year
VAS
Patient reported VAS will be collected at different time intervals. The revision rate was described as the number of patients who had to undergo revision post index surgery. VAS: 0-10 (0=better, 10=worst)
Time frame: Pre-op
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time frame: Post-op 2 ~ 4 weeks
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time frame: Post-op 3 months
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time frame: Post-op 6 months
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time frame: Post-op 1 year
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time frame: Pre-op
NDI
Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst)
Time frame: Post-op 2~4 weeks
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time frame: Post-op 3 months
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time frame: Post-op 6 months
NDI
Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)
Time frame: Post-op 1 year
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Time frame: Pre-op
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Time frame: Post-op 2~4 weeks
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Time frame: Post-op 3 months
Arthrodesis Rates
Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.
Time frame: Post-op 6 months