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BIO4 Clinical Case Study: Cervical Spine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077204
Recruitment Status : Active, not recruiting
First Posted : March 10, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Seton Healthcare Family

Tracking Information
First Submitted Date  ICMJE February 27, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE April 6, 2017
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Radiological assessment : Fusion Status [ Time Frame: Post-op 1 year ]
    This will be used to monitor the fusion status at 1 year post-op
  • Arthrodesis rates [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03077204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Revision rates (if any) [ Time Frame: Post-op 2~4 weeks ]
    As needed, any post-operative surgical revision rates will be accessed
  • Revision rates (if any) [ Time Frame: Post-op 3 months ]
    As needed, any post-operative surgical revision rates will be accessed
  • Revision rates (if any) [ Time Frame: Post-op 6 months ]
    As needed, any post-operative surgical revision rates will be accessed
  • Revision rates (if any) [ Time Frame: Post-op 1 year ]
    As needed, any post-operative surgical revision rates will be accessed
  • VAS [ Time Frame: Pre-op ]
    Patient reported VAS will be collected at different time intervals
  • VAS [ Time Frame: Post-op 2 ~ 4 weeks ]
    Patient reported VAS will be collected at different time intervals
  • VAS [ Time Frame: Post-op 3 months ]
    Patient reported VAS will be collected at different time intervals
  • VAS [ Time Frame: Post-op 6 months ]
    Patient reported VAS will be collected at different time intervals
  • VAS [ Time Frame: Post-op 1 year ]
    Patient reported VAS will be collected at different time intervals
  • NDI [ Time Frame: Pre-op ]
    Patient reported NDI will be collected at different time intervals
  • NDI [ Time Frame: Post-op 2~4 weeks ]
    Patient reported NDI will be collected at different time intervals
  • NDI [ Time Frame: Post-op 3 months ]
    Patient reported NDI will be collected at different time intervals
  • NDI [ Time Frame: Post-op 6 months ]
    Patient reported NDI will be collected at different time intervals
  • NDI [ Time Frame: Post-op year ]
    Patient reported NDI will be collected at different time intervals
  • Arthrodesis rates [ Time Frame: 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
  • Arthrodesis rates [ Time Frame: 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
  • Arthrodesis rates [ Time Frame: 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
  • Arthrodesis rates [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BIO4 Clinical Case Study: Cervical Spine
Official Title  ICMJE Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Disc Disease
  • Trauma (Including Fractures)
  • Spondylolisthesis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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).
Interventions:
  • Biological: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
  • Device: Aviator Anterior Cervical Plating System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077204
Other Study ID Numbers  ICMJE CR-16-109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seton Healthcare Family
Study Sponsor  ICMJE Seton Healthcare Family
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eeric Truumees, MD Seton Spine and Scoliosis Center
PRS Account Seton Healthcare Family
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP