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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIO4 treatment | Other | Patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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. | Post-op 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Post-op 2~4 weeks |
| Revision Rates (if Any) |
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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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Eeric Truumees, MD | Seton Spine and Scoliosis Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seton Spine and Scoliosis Center | Austin | Texas | 78731 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23247591 | Background | 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. | |
| Background | • Osiris Therapeutics-Data on File | ||
| Background | • 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) | ||
| 18280215 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BIO4 Treatment | Participants were treated as per the protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BIO4 Treatment | Treatment group consisted of patient undergoing ACDF using BIO4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 1 year |
|
|
1 year
We reviewed mortality in all our 20 patients
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIO4 Treatment | Patients undergoing ACDF using BIO4 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory distress post-surgery | Surgical and medical procedures | Systematic Assessment | Patient re-intubated for respiratory distress post-surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devender Singh, Research Scientist | Ascension Texas Spine and Scoliosis | 512 324 3580 | 15916 | dpsingh@ascension.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2019 | Oct 21, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D014947 | Wounds and Injuries |
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| D009369 | Neoplasms |
| D011542 | Pseudarthrosis |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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|
| Aviator Anterior Cervical Plating System | Device | 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. |
|
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
| 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 | 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 | 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) | Pre-op |
| VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Post-op 2 ~ 4 weeks |
| VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Post-op 3 months |
| VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Post-op 6 months |
| VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Post-op 1 year |
| NDI | Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst) | Pre-op |
| NDI | Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst) | Post-op 2~4 weeks |
| NDI | Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst) | Post-op 3 months |
| NDI | Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst) | Post-op 6 months |
| NDI | Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst) | 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. | 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. | 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. | 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. | Post-op 6 months |
| Background |
| 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. |
| 19501025 | Background | 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. |
| 25188591 | Background | 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. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Visual Analog Scale | Range: 0-10 0= no pain 10= worst pain | Mean | Full Range | units on a scale |
|
| Neck Disability Index | 0-100 (0=better, 100=worst) | Mean | Full Range | units on a scale |
|
|
| Primary | 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. | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 1 year |
|
|
|
| Secondary | 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 | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 2~4 weeks |
|
|
|
| Secondary | 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 | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 3 months |
|
|
|
| Secondary | 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 | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 6 months |
|
|
|
| Secondary | 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 | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 1 year |
|
|
|
| Secondary | 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) | Patients treated with BIO4 | Posted | Mean | Full Range | units on a scale | Pre-op |
|
|
|
| Secondary | VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 2 ~ 4 weeks |
|
|
|
| Secondary | VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 3 months |
|
|
|
| Secondary | VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 6 months |
|
|
|
| Secondary | VAS | Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 1 year |
|
|
|
| Secondary | NDI | Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Pre-op |
|
|
|
| Secondary | NDI | Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 2~4 weeks |
|
|
|
| Secondary | NDI | Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 3 months |
|
|
|
| Secondary | NDI | Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 6 months |
|
|
|
| Secondary | NDI | Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst) | Patients who underwent ACDF using BIO4 | Posted | Mean | Full Range | units on a scale | Post-op 1 year |
|
|
|
| Secondary | 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. | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Pre-op |
|
|
|
| Secondary | 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. | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 2~4 weeks |
|
|
|
| Secondary | 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. | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 3 months |
|
|
|
| Secondary | 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. | Patients who underwent ACDF using BIO4 | Posted | Number | participants | Post-op 6 months |
|
|
|
| 20 |
| 1 |
| 20 |
| 1 |
| 20 |
|
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| D055009 |
| Spondylosis |
| D005599 | Fractures, Ununited |
| D050723 | Fractures, Bone |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |