Degenerative Disc Disease, Spondylolisthesis, Trauma (Including Fractures)
Conditions
Keywords
Total cervical vertebrectomy, Partial cervical vertebrectomy, Failed previous fusion, Spinal stenosis, Tumor, Decompression of the spinal cord, Pseudoarthrosis, Curvatures, Deformities
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).
Interventions
BIOLOGICAL1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
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.
DEVICEAviator Anterior Cervical Plating System
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.
Sponsors
Seton Healthcare Family
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\>18 years 2. Scheduled 1 or 2-level ACDF spine surgery 3. The capacity to provide informed consent. 4. Subject has one or more of the following diagnoses: 1. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Trauma (including fractures) 3. Tumors 4. Deformities or curvatures (including kyphosis, lordosis, or scoliosis) 5. Pseudoarthrosis 6. Failed previous fusion 7. Decompression of the spinal cord following total or partial cervical vertebrectomy 8. Spondylolisthesis 9. 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. 1. Patients with current or recent history of malignancy or infectious disease. 2. The inability to provide informed consent. 3. Subject has marked local inflammation 4. Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care. 5. Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices. 6. Subject has bone abnormalities preventing safe screw fixation. 7. Subject has any open wounds. 8. 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. 9. Subject has a documented or suspected metal sensitivity. 10. Subject is pregnant. 11. Subject has anatomical structures or physiological performance that would interfere with implant utilization. 12. Subject has inadequate tissue coverage over the operative site. 13. 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. 14. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological Assessment : Fusion Status | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision Rates (if Any) | Post-op 2~4 weeks | 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 | Pre-op | 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) |
| NDI | Pre-op | Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst) |
| Arthrodesis Rates | Pre-op | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIO4 Treatment Treatment group consisted of patient undergoing ACDF using BIO4 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | BIO4 Treatment | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | — |
| Age, Continuous | 57.4 years | — |
| Neck Disability Index | 35 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
| Visual Analog Scale | 4.7 units on a scale | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
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.
Time frame: Post-op 1 year
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Arthrodesis Rates | 0 participants |
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.
Time frame: Post-op 1 year
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Radiological Assessment : Fusion Status | 20 participants |
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.
Time frame: Post-op 3 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Arthrodesis Rates | 0 participants |
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.
Time frame: Post-op 2~4 weeks
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Arthrodesis Rates | 0 participants |
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.
Time frame: Pre-op
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Arthrodesis Rates | 0 participants |
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.
Time frame: Post-op 6 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Arthrodesis Rates | 0 participants |
Secondary
NDI
Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)
Time frame: Post-op 1 year
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | NDI | 9.1 units on a scale |
Secondary
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time frame: Post-op 3 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | NDI | 20.7 units on a scale |
Secondary
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time frame: Post-op 6 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | NDI | 18.7 units on a scale |
Secondary
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
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | NDI | 19.1 units on a scale |
Secondary
NDI
Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time frame: Pre-op
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | NDI | 35 units on a scale |
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
Time frame: Post-op 3 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Revision Rates (if Any) | 0 participants |
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
Time frame: Post-op 2~4 weeks
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Revision Rates (if Any) | 0 participants |
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
Time frame: Post-op 6 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Revision Rates (if Any) | 0 participants |
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
Time frame: Post-op 1 year
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIO4 Treatment | Revision Rates (if Any) | 0 participants |
Secondary
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time frame: Post-op 3 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | VAS | 2.4 units on a scale |
Secondary
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
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | VAS | 2.9 units on a scale |
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)
Time frame: Pre-op
Population: Patients treated with BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | VAS | 4.7 units on a scale |
Secondary
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time frame: Post-op 1 year
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | VAS | 1.2 units on a scale |
Secondary
VAS
Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)
Time frame: Post-op 6 months
Population: Patients who underwent ACDF using BIO4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BIO4 Treatment | VAS | 2 units on a scale |