NCT03077204

BIO4 Clinical Case Study: Cervical Spine

Completed Phase 4 Results posted Last updated 14 January 2022

What this trial tests

Phase 4 trial testing 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). in Degenerative Disc Disease in 20 participants. Completed in 30 January 2020.

Timeline

6 April 2017

Primary endpoint
30 January 2020

30 January 2020

Quick facts

Lead sponsor	Seton Healthcare Family
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	6 April 2017
Primary completion	30 January 2020
Estimated completion	30 January 2020
Sites	1 location across United States

Drugs / interventions tested

• 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). — full drug profile →
• Aviator Anterior Cervical Plating System

Conditions studied

• Degenerative Disc Disease — all drugs for Degenerative Disc Disease →
• Trauma (Including Fractures) — all drugs for Trauma (Including Fractures) →
• Spondylolisthesis — all drugs for Spondylolisthesis →

Sponsor

Seton Healthcare Family — full company profile →

Who can join

19 and older, any sex, with Degenerative Disc Disease or Trauma (Including Fractures). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Radiological Assessment : Fusion Status Primary · 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".

Group	Value	95% CI
BIO4 Treatment	20

Arthrodesis Rates Primary · 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.

Group	Value	95% CI
BIO4 Treatment	0

Revision Rates (if Any) Secondary · 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

Group	Value	95% CI
BIO4 Treatment	0

Revision Rates (if Any) Secondary · 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

Group	Value	95% CI
BIO4 Treatment	0

Revision Rates (if Any) Secondary · 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

Group	Value	95% CI
BIO4 Treatment	0

Revision Rates (if Any) Secondary · 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

Group	Value	95% CI
BIO4 Treatment	0

VAS Secondary · 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)

Group	Value	95% CI
BIO4 Treatment	4.7	0 – 8

VAS Secondary · Post-op 2 ~ 4 weeks

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

Group	Value	95% CI
BIO4 Treatment	2.9	0 – 7

VAS Secondary · Post-op 3 months

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

Group	Value	95% CI
BIO4 Treatment	2.4	0 – 7

VAS Secondary · Post-op 6 months

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

Group	Value	95% CI
BIO4 Treatment	2	0 – 5

VAS Secondary · Post-op 1 year

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

Group	Value	95% CI
BIO4 Treatment	1.2	0 – 6

NDI Secondary · Pre-op

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

Group	Value	95% CI
BIO4 Treatment	35	6 – 68

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BIO4 Treatment

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	BIO4 Treatment
Sepsis	Infections and infestations	—

Other adverse events (1 terms — click to expand)

Reaction	System	BIO4 Treatment
Respiratory distress post-surgery	Surgical and medical procedures	—

Most-reported serious reactions: Sepsis.

Data from ClinicalTrials.gov NCT03077204 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Commercial Bone Grafts Claimed as an Alternative to Autografts: Current Trends for Clinical Applications in Orthopaedics.
   Govoni M, Vivarelli L, Mazzotta A, Stagni C, et al · · 2021 · cited 39× · PMID 34198691 · DOI 10.3390/ma14123290
2. Allografts and Spinal Fusion.
   Cohen JD, Kanim LE, Tronits AJ, Bae HW. · · 2021 · cited 14× · PMID 34376497 · DOI 10.14444/8056