Spinal FusionASTRONCT04439032
Artoss Prospective Spine Registry Outcomes
An observational study of Spinal Fusion, run by Artoss Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- NanoBone Bone Graft Substitute
- How many people
- 330 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Aug 2020to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
OrthoBethesda
Bethesda, Maryland, 20817
Sam Shamsnia MD Neurosurgery
Biloxi, Mississippi, 39532
OrthoArizona
Chandler, Arizona, 85226
Hartford Health Care
Hartford, Connecticut, 06102
SENTA Clinic
San Diego, California, 92108
Sonoran Spine
Tempe, Arizona, 85281
About this study
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery
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.
Read the 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.
- Conditions
- Spinal Fusion
- Being tested
- NanoBone Bone Graft Substitute
- Keywords
- Bone Graft Substitute, Spinal Fusion, Degenerative Disc Disease, Scoliosis, Spine Deformity
- Medical subject headings
- Intervertebral Disc Degeneration, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoBone Bone Graft SubstituteOther
Also called nanoHA-SiO2
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NanoBone Bone Graft Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months
Secondary outcomes (1)
Safety Evaluation
Occurrence of Complications or Adverse Events
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start3 Aug 2020
- Primary completion31 Oct 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artoss Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Cassidy, PhD, Study director, Artoss Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439032
- Sponsor's protocol ID
- SF-100
- Acronym
- ASTRO
- Status last verified
- Feb 2025
- First submitted
- 2 Jun 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT04439032
- Acronym / sponsor ID
- ASTRO / SF-100
- Conditions
- Spinal Fusion
- Keywords
- Bone Graft Substitute, Spinal Fusion, Degenerative Disc Disease, Scoliosis, Spine Deformity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Artoss Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spine Fusion using NanoBone | – | Other: NanoBone Bone Graft SubstituteAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoBone Bone Graft SubstituteAlso: nanoHA-SiO2Synthetic, 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. | Other | Spine Fusion using NanoBone |
Primary outcome
Radiographic Success
Time frame: 12-months
Evidence of bony bridging between vertebral endplates and/or transverse processes of bone grafted vertebrae or absence of motion between vertebral bodies or both.
1 secondary outcome
Safety Evaluation
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Cassidy, PhD study director
Artoss Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion, run by Artoss Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Success (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.