Back to resultsBIO4 Clinical Case Study: Cervical Spine
Primary Purpose
Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
Aviator Anterior Cervical Plating System
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Total cervical vertebrectomy, Partial cervical vertebrectomy, Failed previous fusion, Spinal stenosis, Tumor, Decompression of the spinal cord, Pseudoarthrosis, Curvatures, Deformities
Eligibility Criteria
Inclusion Criteria
- 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)
- Tumors
- 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
Exclusion Criteria 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conditions will be excluded, or if enrolled and found to be ineligible and do not fit the inclusion criteria, will be withdrawn from the study.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.
Sites / Locations
- Seton Spine and Scoliosis Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
BIO4 treatment
Arm Description
Patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
Outcomes
Primary Outcome Measures
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".
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.
Secondary Outcome Measures
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
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
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
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
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)
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
NDI
Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst)
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
NDI
Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)
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.
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.
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.
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.
Full Information
NCT ID
NCT03077204
First Posted
February 27, 2017
Last Updated
December 16, 2021
Sponsor
Seton Healthcare Family
1. Study Identification
Unique Protocol Identification Number
NCT03077204
Brief Title
BIO4 Clinical Case Study: Cervical Spine
Official Title
Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seton Healthcare Family
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
Keywords
Total cervical vertebrectomy, Partial cervical vertebrectomy, Failed previous fusion, Spinal stenosis, Tumor, Decompression of the spinal cord, Pseudoarthrosis, Curvatures, Deformities
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIO4 treatment
Arm Type
Other
Arm Description
Patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
Intervention Type
Biological
Intervention Name(s)
1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aviator Anterior Cervical Plating System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiological Assessment : Fusion Status
Description
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
Title
Arthrodesis Rates
Description
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
Secondary Outcome Measure Information:
Title
Revision Rates (if Any)
Description
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
Title
Revision Rates (if Any)
Description
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
Title
Revision Rates (if Any)
Description
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
Title
Revision Rates (if Any)
Description
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 1 year
Title
VAS
Description
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
Title
VAS
Description
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time Frame
Post-op 2 ~ 4 weeks
Title
VAS
Description
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time Frame
Post-op 3 months
Title
VAS
Description
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time Frame
Post-op 6 months
Title
VAS
Description
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time Frame
Post-op 1 year
Title
NDI
Description
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time Frame
Pre-op
Title
NDI
Description
Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst)
Time Frame
Post-op 2~4 weeks
Title
NDI
Description
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time Frame
Post-op 3 months
Title
NDI
Description
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time Frame
Post-op 6 months
Title
NDI
Description
Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)
Time Frame
Post-op 1 year
Title
Arthrodesis Rates
Description
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
Title
Arthrodesis Rates
Description
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
Title
Arthrodesis Rates
Description
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
Title
Arthrodesis Rates
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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)
Tumors
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
Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eeric Truumees, MD
Organizational Affiliation
Seton Spine and Scoliosis Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seton Spine and Scoliosis Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23247591
Citation
Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.
Results Reference
background
Citation
• Osiris Therapeutics-Data on File
Results Reference
background
Citation
• Bourke HE, Sandison A, Hughes SPF and Reichert ILH. Vascular Endothelial Growth Factor (VEGF) in Human Periosteum- Normal Expression and Response to Fracture, "Journal of Bone and Joint Surgery, British Volume (2003)
Results Reference
background
PubMed Identifier
18280215
Citation
Epstein NE. An analysis of noninstrumented posterolateral lumbar fusions performed in predominantly geriatric patients using lamina autograft and beta tricalcium phosphate. Spine J. 2008 Nov-Dec;8(6):882-7. doi: 10.1016/j.spinee.2007.11.005. Epub 2008 Feb 14.
Results Reference
background
PubMed Identifier
19501025
Citation
Epstein NE. Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions. Spine J. 2009 Aug;9(8):630-8. doi: 10.1016/j.spinee.2009.04.007. Epub 2009 Jun 4.
Results Reference
background
PubMed Identifier
25188591
Citation
Eastlack RK, Garfin SR, Brown CR, Meyer SC. Osteocel Plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study. Spine (Phila Pa 1976). 2014 Oct 15;39(22):E1331-7. doi: 10.1097/BRS.0000000000000557.
Results Reference
background
Learn more about this trial
BIO4 Clinical Case Study: Cervical Spine
We'll reach out to this number within 24 hrs