NCT03077204

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

April 6, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 14, 2022

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

2.8 years

First QC Date

February 27, 2017

Results QC Date

September 23, 2021

Last Update Submit

December 16, 2021

Conditions

Degenerative Disc DiseaseTrauma (Including Fractures)Spondylolisthesis

Keywords

Total cervical vertebrectomyPartial cervical vertebrectomyFailed previous fusionSpinal stenosisTumorDecompression of the spinal cordPseudoarthrosisCurvaturesDeformities

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (18)

  • Revision Rates (if Any)

    Post-op 2~4 weeks

  • Revision Rates (if Any)

    Post-op 3 months

  • Revision Rates (if Any)

    Post-op 6 months

  • Revision Rates (if Any)

    Post-op 1 year

  • VAS

    Pre-op

  • +13 more secondary outcomes

Study Arms (1)

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).

Biological: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).Device: Aviator Anterior Cervical Plating System

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.

BIO4 treatment
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.

BIO4 treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
  • Trauma (including fractures)
  • Tumors
  • Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
  • Pseudoarthrosis
  • Failed previous fusion
  • Decompression of the spinal cord following total or partial cervical vertebrectomy
  • Spondylolisthesis
  • Spinal stenosis

You may not qualify if:

  • Patients with current or recent history of malignancy or infectious disease.
  • The inability to provide informed consent.
  • Subject has marked local inflammation
  • Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
  • Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices.
  • Subject has bone abnormalities preventing safe screw fixation.
  • Subject has any open wounds.
  • 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.
  • Subject has a documented or suspected metal sensitivity.
  • Subject is pregnant.
  • Subject has anatomical structures or physiological performance that would interfere with implant utilization.
  • Subject has inadequate tissue coverage over the operative site.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seton Spine and Scoliosis Center

Austin, Texas, 78731, United States

Location

Related Publications (6)

  • 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.

    PMID: 23247591BACKGROUND

  • • 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)

    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.

    PMID: 18280215BACKGROUND

  • 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.

    PMID: 19501025BACKGROUND

  • 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.

    PMID: 25188591BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DegenerationWounds and InjuriesSpondylolisthesisSpinal StenosisNeoplasmsPseudarthrosisCongenital Abnormalities

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosisFractures, UnunitedFractures, BoneCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Devender Singh, Research Scientist
Organization
Ascension Texas Spine and Scoliosis
dpsingh@ascension.org
512 324 3580

Study Officials

  • Eeric Truumees, MD

    Seton Spine and Scoliosis Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 10, 2017

Study Start

April 6, 2017

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

January 14, 2022

Results First Posted

January 14, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)