Artoss Prospective Spine Registry Outcomes (ASTRO)

STATUS

Recruiting
End date

Jun 11, 2024
participants needed

250
sponsor

Artoss Inc.

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Updated on 11 March 2022

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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 Identifier	NCT04439032
Sponsor	Artoss Inc.
Last Modified on	11 March 2022

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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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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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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Artoss Prospective Spine Registry Outcomes (ASTRO)