Clinical trial NCT04439032: Artoss Prospective Spine Registry Outcomes
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Fusion
Keywords: Bone Graft Substitute
Spinal Fusion
Degenerative Disc Disease
Scoliosis
Spine Deformity
Lead sponsor: Artoss Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 criteria: 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 outcomes:
measure: Radiographic Success
timeFrame: 12-months
Secondary outcomes:
measure: Safety Evaluation
timeFrame: 12-months
Other outcomes:
measure: Clinical Success
timeFrame: 12-months
measure: Function
timeFrame: 12-months
Locations:
city: Chandler
country: United States
facility: OrthoArizona
state: Arizona
city: Tempe
country: United States
facility: Sonoran Spine
state: Arizona
city: San Diego
country: United States
facility: SENTA Clinic
state: California
city: Hartford
country: United States
facility: Hartford Health Care
state: Connecticut
city: Bethesda
country: United States
facility: OrthoBethesda
state: Maryland
city: Biloxi
country: United States
facility: Sam Shamsnia MD Neurosurgery
state: Mississippi
Study officials:
affiliation: Artoss Inc.
name: Jim Cassidy, PhD
role: STUDY_DIRECTOR
References: