Who is eligible for clinical trial NCT04439032?

Participants must meet protocol criteria for Spinal Fusion. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04439032 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-02-11

Artoss Prospective Spine Registry Outcomes (NCT04439032)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Artoss Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).

Location: OrthoArizona — Chandler, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

OrthoArizona — Chandler, Arizona
Sonoran Spine — Tempe, Arizona
SENTA Clinic — San Diego, California
Hartford Health Care — Hartford, Connecticut
OrthoBethesda — Bethesda, Maryland
Sam Shamsnia MD Neurosurgery — Biloxi, Mississippi

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗