Artoss Prospective Spine Registry Outcomes

Overview

This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.

Full Title of Study: “Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2023

Detailed Description

This multicenter prospective patient registry was developed with the aim of documenting how spine and neurosurgeons are utilizing the NanoBone products along with relevant patient outcomes. These outcomes include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

The primary objective of this study is to document and analyze the use of NanoBone products in spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only, no other BGS or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

Interventions

  • Other: NanoBone Bone Graft Substitute
    • Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.

Arms, Groups and Cohorts

  • Spine Fusion using NanoBone
    • All patients in the study will be drawn from the individual surgeons’ practice. Patients will be candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery but have not completed their standard of care follow-up as determined by the surgeon’s practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient.

Clinical Trial Outcome Measures

Primary Measures

  • Radiographic Success
    • Time Frame: 12-months
    • Evidence of bony bridging between vertebral endplates and/or transverse processes of bone grafted vertebrae or absence of motion between vertebral bodies or both.

Secondary Measures

  • Safety Evaluation
    • Time Frame: 12-months
    • Occurrence of Complications or Adverse Events

Participating in This Clinical Trial

Inclusion Criteria

  • Patient aged 18 years or older
  • Patient is diagnosed with a degenerative spine disorder requiring spinal fusion, has failed conservative treatment, and has decided to undergo surgery.
  • The surgeon has determined that a NanoBone product is or was clinically indicated, and will use or have used the product as a stand-alone bone graft substitute or in combination with local autograft only (no iliac crest harvesting, other BGS, or biologic {defined as containing growth factors, cytokines, proteins, or cells} used).
  • Patient capable of understanding the content of the Informed Consent Form
  • Patient willing and able to participate in the registry protocol including SOC follow-up visits and clinical evaluations.
  • Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the Declaration of Helsinki.

Exclusion Criteria

• Severe vascular or neurological disease

  • Uncontrolled diabetes
  • Severe degenerative disease (other than degenerative disc disease)
  • Severely impaired renal function
  • Hypercalcemia, abnormal calcium metabolism
  • Existing acute or chronic infections, especially at the site of the operation
  • Inflammatory bone disease such as osteomyelitis
  • Malignant tumors
  • Patients who are or plan to become pregnant.
  • Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Artoss Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Steven M Czop, RPh, Study Director, Artoss Inc.
  • Overall Contact(s)
    • Steven M Czop, RPh, (320) 259-4321, sczop@artossinc.com

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