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Clinical Trials in the USA / NCT04439032
Active, not recruiting Observational

Artoss Prospective Spine Registry Outcomes

NCT04439032 · tracked via the Priya Life Science USA tracker
Sponsor
Artoss Inc.
Phase
Observational
Started
2020-08-03
Last updated
2025-02-12

Condition(s) studied

Spinal Fusion

Investigational drug(s) / intervention(s)

NanoBone Bone Graft Substitute

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04439032 on ClinicalTrials.gov ↗ ← All trials in the USA