CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03077204
NCT03077204Phase 4Completed
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Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery

Seton Healthcare Family·interventional·Posted Mar 10, 2017·Updated Jan 14, 2022

In Brief

A Phase 4 clinical trial evaluating 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). and Aviator Anterior Cervical Plating System for Degenerative Disc Disease and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 10, 2017
Enrollment StartApr 6, 2017
Primary CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.3 years ago

Interventions

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.

Aviator Anterior Cervical Plating Systemdevice

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.