NanoBone® Synthetic Bone Graft for Spinal Fusion

(BONE Trial)

Overseen By Jim Cassidy, Ph.D..

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Artoss Inc.

Must not be taking: Corticosteroids

Disqualifiers: Morbid obesity, Osteoporosis, Diabetes, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The objectives of this longitudinal study are to assess and measure fusion status (fused or not fused) and rate of bony fusion using NanoBone® Synthetic Bone Graft in patients requiring one to two level lumbar posterolateral fusion procedures with or without commercially available rigid spinal instrumentation. Our hypothesis is that the Nanobone synthetic bone graft will be as effective at creating a fusion in the lumbar spine as compared with a local bone graft. Each subject will serve as their own control during this study, as patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently receiving corticosteroids for more than 2 years at a dose greater than 5 mg prednisolone equivalent per day, you would be excluded from the trial. It's best to discuss your specific medications with the trial coordinators.

What data supports the idea that NanoBone® Synthetic Bone Graft for Spinal Fusion is an effective treatment?

The available research shows that NanoBone is effective because it is designed to be similar to natural bone, allowing it to be broken down and replaced by the body's own bone cells. This process is similar to how natural bone heals and remodels itself. Additionally, synthetic bone grafts like NanoBone are becoming more popular because they are easy to store and use, and they don't require taking bone from another part of the patient's body, which can be painful and cause complications. While there are other synthetic bone grafts available, NanoBone's unique structure and composition make it a promising option for spinal fusion. ^{1 2 3 4 5}

What safety data exists for NanoBone Synthetic Bone Graft?

The safety data for NanoBone Synthetic Bone Graft indicates that it is biodegraded by osteoclasts in a manner similar to natural bone remodeling, suggesting good biocompatibility. However, there is limited well-designed, controlled clinical trial data available for synthetic bone graft substitutes, including NanoBone. A systematic review found that while some studies suggest safety and efficacy, many have a high incidence of bias, making it difficult to draw definitive conclusions. Therefore, while initial data is promising, more rigorous studies are needed to fully establish the safety profile of NanoBone in spinal fusion procedures. ^{2 5 6 7 8}

Is NanoBone a promising treatment for spinal fusion?

Yes, NanoBone is a promising treatment for spinal fusion. It is a synthetic bone graft that helps new bone grow by providing a structure for bone cells to attach to. It is biodegradable, meaning it breaks down naturally in the body as new bone forms. This makes it a good alternative to using a patient's own bone, which can be painful to harvest. NanoBone is also easy to store and use, making it a convenient option for doctors. ^{1 2 5 7 9}

Research Team

Patrick Connelly, MD

Principal Investigator

UMass Memorial Health

Eligibility Criteria

This trial is for adults aged 18-85 with certain spine conditions (1 or 2 level degenerative disc disease or spondylolisthesis grades 1-3) needing fusion surgery. Participants must be able to follow the study plan and not have infections, severe obesity, uncontrolled diabetes, autoimmune diseases, active cancer, mental incapacity to consent, previous lumbar fusion attempts, or other health issues that could affect results.

Inclusion Criteria

My bones have stopped growing.

I am willing and able to follow through with all post-surgery check-ups and rehab.

I have a diagnosis of mild to moderate spinal condition needing surgery.

Exclusion Criteria

Pregnant women

I have an active cancer.

Non-English speaking subjects. These subjects are excluded because they would not be able to complete the English-language surveys required during this study. Only English language versions of these surveys have been validated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Operative

Participants undergo posterolateral spinal fusion with NanoBone graft on the right side and local bone graft on the left side

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored post-discharge and at 4 months, 1 year, and 2 years postoperatively with clinical examinations and imaging

24 months

4 visits (in-person)

Treatment Details

Interventions

• NanoBone

Trial Overview The study tests NanoBone® Synthetic Bone Graft's effectiveness in spinal fusion compared to local bone grafts. Patients will receive NanoBone on one side of their spine and a local graft on the other as controls. The goal is to see if NanoBone can equally promote bone healing in the lumbar region.

Participant Groups

Group I: Single arm subject is own control Experimental Treatment 1 Intervention

Posterolateral fusion is bilateral, patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.

NanoBone is already approved in United States, European Union for the following indications:

Approved in United States as NanoBone for:

• Surgically created osseous defects or osseous defects resulting from traumatic injury or surgical procedures

Approved in European Union as NanoBone for:

• Bone defects requiring grafting
• Orthopedic and dental applications

Who Is Running the Clinical Trial?

Artoss Inc.

Lead Sponsor

Trials

4

Recruited

770+

Findings from Research

A glass-reinforced hydroxyapatite synthetic bone substitute was successfully used in 14 veterinary cases to fill bone defects, promoting bone regeneration and enhancing surgical outcomes without causing adverse reactions.

The synthetic bone graft improved the quality of life for the animals by reducing pain and recovery time while increasing bone stability, making it a viable alternative to autologous bone grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Bonelike® as synthetic bone graft in orthopaedic and oral surgery in veterinary clinical cases. Campos, JM., Sousa, AC., Pinto, PO., et al.[2023]

Synthetic bone graft substitutes, which include materials like hydroxyapatite and tricalcium phosphate, are becoming more popular in the U.S. bone graft market, currently representing about 10% of procedures, with their use expected to grow due to their advantages over traditional grafts.

While these substitutes offer benefits such as unlimited supply and easy sterilization, they also have limitations like brittleness and variable resorption rates, which have led to their primary use as bone graft extenders rather than direct replacements for bone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonallograft osteoconductive bone graft substitutes. Bucholz, RW.[2022]

Autologous bone graft from the iliac crest remains the gold standard for spinal fusion due to its essential properties for achieving solid fusion, but it can cause significant donor site morbidity.

Research is increasingly focused on synthetic and biologically active alternatives, such as recombinant bone morphogenetic proteins (BMPs) and synthetic ceramics, which aim to provide similar or improved outcomes without the complications associated with harvesting autologous grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary alternatives to synthetic bone grafts for spine surgery. Brandoff, JF., Silber, JS., Vaccaro, AR.[2010]

In a study involving 70 New Zealand White rabbits, the nanosynthetic silicated calcium phosphate putty (OstP) combined with autograft showed an impressive 100% fusion success rate at 26 weeks, outperforming the collagen-biphasic calcium phosphate putty (MasP) and demonstrating similar efficacy to autograft alone.

The OstP extender not only facilitated effective spinal fusion but also promoted increased bone formation and normal healing responses, indicating its potential as a viable alternative to traditional autograft methods in spinal fusion surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a nanosynthetic bone graft substitute as a bone graft extender in rabbit posterolateral fusion. Conway, JC., Oliver, RA., Wang, T., et al.[2022]

NanoBone, a new synthetic bone grafting substitute made from nanocrystalline hydroxyapatite and silica, shows excellent osteoconductivity due to its highly porous structure, which supports bone growth.

The material is completely biodegradable and is resorbed by osteoclasts in a way similar to natural bone remodeling, promoting the formation of new bone tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The manufacture of synthetic non-sintered and degradable bone grafting substitutes. Gerike, W., Bienengräber, V., Henkel, KO., et al.[2015]

In a study of 32 patients undergoing lumbar posterolateral fusion with PolyBone®, a beta-tricalcium phosphate synthetic graft, significant reductions in back and leg pain were observed over 12 months, with NRS scores dropping from 8.0 to 1.0 for leg pain and from 6.7 to 1.7 for back pain.

The fusion success rate was high, with 83.3% of patients achieving stage IV fusion bridges at 12 months, indicating that PolyBone® can effectively replace autologous bone grafts while minimizing donor site morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic Analysis of Instrumented Posterolateral Fusion Mass Using Mixture of Local Autologous Bone and b-TCP (PolyBone®) in a Lumbar Spinal Fusion Surgery. Park, JH., Choi, CG., Jeon, SR., et al.[2022]

Both NanoBone(®) and BioOss(®) demonstrated low cytotoxicity and good biocompatibility when tested with human osteoblasts, indicating they are safe for clinical use.

NanoBone(®) showed superior performance in promoting the proliferation of human osteoblasts compared to BioOss(®), suggesting it may be a more effective option for bone tissue engineering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of in vitro biocompatibility of NanoBone(®) and BioOss(®) for human osteoblasts. Liu, Q., Douglas, T., Zamponi, C., et al.[2016]

A systematic review of 24 studies on spinal fusion procedures found that a composite bone substitute demonstrated safety and efficacy comparable to autologous bone grafts, with some superior outcomes, based on a high-quality RCT.

Most studies included in the review had a high incidence of bias, indicating that while allografts and synthetic grafts are used, their efficacy and safety need to be carefully evaluated before use in spinal fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal fusion procedures in the adult and young population: a systematic review on allogenic bone and synthetic grafts when compared to autologous bone. Salamanna, F., Tschon, M., Borsari, V., et al.[2021]

The study of a new nanoporous grafting material, NanoBone(s), in 12 patients showed that it has osteoconductive properties, promoting early bone formation and integration with the host's bone during the healing process.

Histological analysis revealed that NanoBone(s) supports the transformation of graft material into lamellar bone, with active involvement of osteoclast-like cells and pre-osteoblasts, indicating its effectiveness in bone regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunohistochemical characterization of nanocrystalline hydroxyapatite silica gel (NanoBone(r)) osteogenesis: a study on biopsies from human jaws. Götz, W., Gerber, T., Michel, B., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Application of Bonelike® as synthetic bone graft in orthopaedic and oral surgery in veterinary clinical cases. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Nonallograft osteoconductive bone graft substitutes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Contemporary alternatives to synthetic bone grafts for spine surgery. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

The efficacy of a nanosynthetic bone graft substitute as a bone graft extender in rabbit posterolateral fusion. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

The manufacture of synthetic non-sintered and degradable bone grafting substitutes. [2015]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Radiographic Analysis of Instrumented Posterolateral Fusion Mass Using Mixture of Local Autologous Bone and b-TCP (PolyBone®) in a Lumbar Spinal Fusion Surgery. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

Comparison of in vitro biocompatibility of NanoBone(®) and BioOss(®) for human osteoblasts. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Spinal fusion procedures in the adult and young population: a systematic review on allogenic bone and synthetic grafts when compared to autologous bone. [2021]

9. Denmark pubmed.ncbi.nlm.nih.gov

Immunohistochemical characterization of nanocrystalline hydroxyapatite silica gel (NanoBone(r)) osteogenesis: a study on biopsies from human jaws. [2016]