Artoss Prospective Spine Registry Outcomes (ASTRO)

  • STATUS
    Recruiting
  • End date
    Jun 11, 2024
  • participants needed
    250
  • sponsor
    Artoss Inc.
Updated on 11 March 2022
cytokines
autograft
bone graft
spine disorder

Summary

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.

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.

Details
Condition Spinal Fusion
Treatment NanoBone Bone Graft Substitute
Clinical Study IdentifierNCT04439032
SponsorArtoss Inc.
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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