Artoss Prospective Spine Registry Outcomes

Spinal Fusion Clinical Trial

— ASTRO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04439032
• Other study ID #: SF-100
• Status: Active, not recruiting
• Start date: August 3, 2020
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Artoss Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Fusion

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	OrthoBethesda	Bethesda	Maryland
United States	Sam Shamsnia MD Neurosurgery	Biloxi	Mississippi
United States	OrthoArizona	Chandler	Arizona
United States	Hartford Health Care	Hartford	Connecticut
United States	SENTA Clinic	San Diego	California
United States	Sonoran Spine	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Artoss Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Success	Improvement from baseline in Visual Analog Scale (VAS) pain score (0= no pain, 10=worst possible pain)	12-months
Other	Function	Improvement from baseline in Oswestry Disability Index (ODI) or Neck Disability Index (NDI) Scale (0=no disability-100=totally disabled)	12-months
Primary	Radiographic Success	Evidence of bony bridging between vertebral endplates and/or transverse processes of bone grafted vertebrae or absence of motion between vertebral bodies or both.	12-months
Secondary	Safety Evaluation	Occurrence of Complications or Adverse Events	12-months

External Links

•   Sponsor Website