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Artoss Prospective Spine Registry Outcomes | Clinical Trials | Clareo Health

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Artoss Prospective Spine Registry Outcomes

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

NCT04439032•Artoss Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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.

Locations (6)

OrthoArizona

Chandler, Arizona, United States

Sonoran Spine

Tempe, Arizona, United States

SENTA Clinic

San Diego, California, United States

Hartford Health Care

Hartford, Connecticut, United States

OrthoBethesda

Bethesda, Maryland, United States

Sam Shamsnia MD Neurosurgery

Biloxi, Mississippi, United States

Key Dates

Start Date

August 3, 2020

Primary Completion Date

October 31, 2024

Completion Date

June 30, 2025

Last Updated

February 12, 2025

Enrollment

330

ACTUAL participants

Conditions

Spinal Fusion

Interventions

NanoBone Bone Graft Substitute

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Artoss Prospective Spine Registry Outcomes

Inclusion Criteria

Exclusion Criteria

Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery

Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion

Kids With Iron Deficiency and Scoliosis

Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery

Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion - A Single-case Experimental Study

Spine Registration Using 3D Scanning