BIO4 Clinical Case Study: Cervical Spine

• Sponsor: Seton Healthcare Family (Other)
• Overall Status: Completed
• CT.gov ID: NCT03077204
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 33.8
• Patients Per Site Per Month: 0.6

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease; Trauma (Including Fractures); Spondylolisthesis	Biological: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).; Device: Aviator Anterior Cervical Plating System	Phase 4

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery
• Actual Study Start Date: Apr 6, 2017
• Actual Primary Completion Date: Jan 30, 2020
• Actual Study Completion Date: Jan 30, 2020

Arms and Interventions

Arm

Intervention/Treatment

Other: 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).

Biological: 1 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.; Device: Aviator 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.

Outcome Measures

Primary Outcome Measures

1. 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".

2. 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 Outcome Measures

1. 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

2. Revision Rates (if Any) [Post-op 3 months]

   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

3. Revision Rates (if Any) [Post-op 6 months]

   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

4. Revision Rates (if Any) [Post-op 1 year]

   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

5. 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)

6. VAS [Post-op 2 ~ 4 weeks]

   Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

7. VAS [Post-op 3 months]

   Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

8. VAS [Post-op 6 months]

   Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

9. VAS [Post-op 1 year]

   Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

10. NDI [Pre-op]

    Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)

11. NDI [Post-op 2~4 weeks]

    Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst)

12. NDI [Post-op 3 months]

    Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)

13. NDI [Post-op 6 months]

    Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)

14. NDI [Post-op 1 year]

    Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)

15. 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.

16. Arthrodesis Rates [Post-op 2~4 weeks]

    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.

17. Arthrodesis Rates [Post-op 3 months]

    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.

18. Arthrodesis Rates [Post-op 6 months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

5. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

6. Trauma (including fractures)

7. Tumors

8. Deformities or curvatures (including kyphosis, lordosis, or scoliosis)

9. Pseudoarthrosis

10. Failed previous fusion

11. Decompression of the spinal cord following total or partial cervical vertebrectomy

12. Spondylolisthesis

13. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seton Spine and Scoliosis Center	Austin	Texas	United States	78731

Sponsors and Collaborators

• Seton Healthcare Family

Investigators

• Principal Investigator: Eeric Truumees, MD, Seton Spine and Scoliosis Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 28, 2019

More Information

Publications

• • 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)
• • Osiris Therapeutics-Data on File
• 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.
• 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.
• 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.
• 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. Review.

• Responsible Party: Seton Healthcare Family
• ClinicalTrials.gov Identifier: NCT03077204
• Other Study ID Numbers: CR-16-109
• First Posted: Mar 10, 2017
• Last Update Posted: Jan 14, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Seton Healthcare Family: Total cervical vertebrectomy; Partial cervical vertebrectomy; Failed previous fusion; Spinal stenosis; Tumor; Decompression of the spinal cord; Pseudoarthrosis; Curvatures; Deformities
• Additional relevant MeSH terms: Intervertebral Disc Degeneration; Spondylolisthesis

Study Results

Participant Flow

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Participants were treated as per the protocol.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Treatment group consisted of patient undergoing ACDF using BIO4
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 80%
>=65 years	4 20%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	57.4
Sex: Female, Male (Count of Participants)
Female	5 25%
Male	15 75%
Race and Ethnicity Not Collected (Count of Participants)
Visual Analog Scale (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	4.7
Neck Disability Index (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	35

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	20 100%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients treated with BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	4.7

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	2.9

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	2.4

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	2

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	1.2

12. Secondary Outcome

Title	NDI
Description	Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)
Time Frame	Pre-op

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	35

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	19.1

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	20.7

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Mean (Full Range) [units on a scale]	18.7

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	9.1±2.4(0-36)
Measure Participants	20
Mean (Full Range) [units on a scale]	9.1

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

19. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who underwent ACDF using BIO4

Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
Measure Participants	20
Number [participants]	0 0%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	We reviewed mortality in all our 20 patients
Arm/Group Title	BIO4 Treatment
Arm/Group Description	Patients undergoing ACDF using BIO4
All Cause Mortality
	BIO4 Treatment
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	BIO4 Treatment
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Infections and infestations
Sepsis	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	BIO4 Treatment
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Surgical and medical procedures
Respiratory distress post-surgery	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.