Artoss Prospective Spine Registry Outcomes

NCT04439032 | Active Not Recruiting DMC

• 1 other identifier: SF-100
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Spinal Fusion

Keywords

Bone Graft Substitute; Spinal Fusion; Degenerative Disc Disease; Scoliosis; Spine Deformity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Evaluation

  12-months

Other Outcomes (2)

• Clinical Success

  12-months

• Function

  12-months

Study Arms (1)

Spine Fusion using NanoBone

All patients in the study will be drawn from the individual surgeons' practice. Patients will be candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient.

Other: NanoBone Bone Graft Substitute

Interventions

NanoBone Bone Graft Substitute OTHER

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.

Also known as: nanoHA-SiO2

Spine Fusion using NanoBone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in the study will be drawn from the individual surgeons' practice. Patients will be candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. The choice of a NanoBone product is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Artoss Inc.: lead

Study Sites (6)

OrthoArizona

Chandler, Arizona, 85226, United States

Location

Sonoran Spine

Tempe, Arizona, 85281, United States

Location

SENTA Clinic

San Diego, California, 92108, United States

Location

Hartford Health Care

Hartford, Connecticut, 06102, United States

Location

OrthoBethesda

Bethesda, Maryland, 20817, United States

Location

Sam Shamsnia MD Neurosurgery

Biloxi, Mississippi, 39532, United States

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Scoliosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Curvatures

Study Officials

• Jim Cassidy, PhD

  Artoss Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 19, 2020
• Study Start: August 3, 2020
• Primary Completion: October 31, 2024
• Study Completion: June 30, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)