Artoss Prospective Spine Registry Outcomes (ASTRO)

Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Fusion
• Intervention / Treatment: Other: NanoBone Bone Graft Substitute

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.

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85226
      • OrthoArizona
    • Tempe, Arizona, United States, 85281
      • Sonoran Spine
  • California
    • San Diego, California, United States, 92108
      • Senta Clinic
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Health Care
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • OrthoBethesda
  • Mississippi
    • Biloxi, Mississippi, United States, 39532
      • Sam Shamsnia MD Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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. The choice of a NanoBone product is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: nanoHA-SiO2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	Occurrence of Complications or Adverse Events	12-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Improvement from baseline in Visual Analog Scale (VAS) pain score (0= no pain, 10=worst possible pain)	12-months
Function	Improvement from baseline in Oswestry Disability Index (ODI) or Neck Disability Index (NDI) Scale (0=no disability-100=totally disabled)	12-months

Collaborators and Investigators

• Sponsor: Artoss Inc.
• Investigators: Study Director: Jim Cassidy, PhD, Artoss Inc.

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): October 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Scoliosis; Degenerative Disc Disease; Spinal Fusion; Bone Graft Substitute; Spine Deformity
• Other Study ID Numbers: SF-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No