NanoBone® Synthetic Bone Graft for Spinal Fusion

(BONE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Patrick Connelly, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Artoss Inc.

No Placebo Group

Approved in 2 Jurisdictions

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

I am between 18 and 85 years old.

My bones have stopped growing.

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

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.

Treatment Details

Interventions

• NanoBone (Synthetic Bone Graft)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UMass Memorial Health Care Worcester, MA

Who Is Running the Clinical Trial?

Artoss Inc.

Lead Sponsor

Trials

4

Patients Recruited

770+

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] Autologous bone remains the gold standard grafting substrate for bone fusions used for small gaps and critical defects. However, significant morbidity is associated with the harvesting of autologous bone grafts and, for that reason, alternative bone graft substitutes have been developed. In the present case series, a glass-reinforced hydroxyapatite synthetic bone substitute, with osteoinductive and osteoconductive proprieties, was applied. This synthetic bone substitute comprises the incorporation of P2O5-CaO glass-based system within a hydroxyapatite matrix, moulded into spherical pellets with 250-500 μm of diameter. A total of 14 veterinary clinical cases of appendicular bone defects and maxillary / mandibular bone defects are described. In all clinical cases, the synthetic bone substitute was used to fill bone defects, enhancing bone regeneration and complementing the recommended surgical techniques. Results demonstrated that it is an appropriate synthetic bone graft available to be used in veterinary patients. It functioned as a space filler in association with standard orthopaedic and odontological procedures of stabilization, promoting a faster bone fusion without any local or systemic adverse reactions. This procedure improves the animals' quality of life, decreasing pain and post-operative recovery period, as well as increasing bone stability improving positive clinical outcomes.

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

Nonallograft osteoconductive bone graft substitutes. [2022] An estimated 500,000 to 600,000 bone grafting procedures are done annually in the United States. Approximately (1/2) of these surgeries involve spinal arthrodesis whereas 35% to 40% are used for general orthopaedic applications. Synthetic bone graft substitutes currently represent only 10% of the bone graft market, but their share is increasing as experience and confidence in their use are accrued. Despite 15 to 20 years of clinical experience with various synthetic substitutes, there have been few welldesigned, controlled clinical trials of these implants. Synthetic bone graft substitutes consist of hydroxyapatite, tricalcium phosphate, calcium sulfate, or a combination of these minerals. Their fabrication technique, crystallinity, pore dimensions, mechanical properties, and resorption rate vary. All synthetic porous substitutes share numerous advantages over autografts and allografts including their unlimited supply, easy sterilization, and storage. However, the degree to which the substitute provides an osteoconductive structural framework or matrix for new bone ingrowth differs among implants. Disadvantages of ceramic implants include brittle handling properties, variable rates of resorption, poor performance in diaphyseal defects, and potentially adverse effects on normal bone remodeling. These inherent weaknesses have refocused their primary use to bone graft extenders and carriers for pharmaceuticals. The composition, histologic features, indications, and clinical experience of several of the synthetic bone graft substitutes approved for orthopaedic use in the United States are reviewed.

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

Contemporary alternatives to synthetic bone grafts for spine surgery. [2010] The goal in performing spinal fusion techniques is to achieve solid fusion, which will maximize clinical outcomes. This goal has generated enormous interest in developing bone graft alternatives or extenders that enhance or replace autologous bone graft. Autogenous bone graft from the iliac crest is still the gold standard for graft materials because it has all 3 properties essential for adequate fusion. The search for a synthetic graft as good as or better than iliac crest bone graft has recently intensified with the emphasis on minimizing the invasiveness of surgical techniques, including harvest of iliac crest autograft (such harvesting can be associated with significant donor site morbidity). Increasingly being studied are biologically active substances intended to extend, enhance, or even replace autologous graft. These substances include (a) allograft cancellous chips and (b) cortical spacers that are both osteoconductive (provide bone scaffold) and weakly osteoinductive (promote new bone formation), including demineralized bone matrix products. Human recombinant bone morphogenetic proteins (BMPs), including recombinant human BMP-2 (rhBMP-2) and recombinant human osteogenic protein 1 (rhOP-1 or rhBMP-7), are being investigated in human clinical trials and show promise as autologous bone graft substitutes. Synthetic bone grafts (ceramics), such as hydroxyapatite and beta-tricalcium phosphate, provide scaffolds similar to those of autologous bone, are plentiful and inexpensive, and are not associated with donor morbidity. Furthermore, adding silicon may increase the bioactivity of calcium phosphate and enhance interactions at the graft-host interface.

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] Synthetic bone graft substitutes are commonly used in spinal fusion surgery. Preclinical data in a model of spinal fusion to support their efficacy is an important component in clinical adoption to understand how these materials provide a biological and mechanical role in spinal fusion.

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

The manufacture of synthetic non-sintered and degradable bone grafting substitutes. [2015] A new synthetic bone grafting substitute (NanoBone, ARTOSS GmbH, Germany) is presented. This is produced by a new technique, the sol-gel-method. This bone grafting substitute consists of nanocrystalline hydroxyapatite (HA) and nanostructured silica (SiO2). By achieving a highly porous structure good osteoconductivity can be seen. In addition, the material will be completely biodegraded and new own bone is formed. It has been demonstrated that NanoBone is biodegraded by osteoclasts in a manner comparable to the natural bone remodelling process.

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] Although iliac crest autograft is the gold standard for lumbar fusion, the morbidity of donor site leads us to find an alternatives to replace autologous bone graft. Ceramic-based synthetic bone grafts such as hydroxyapatite (HA) and b-tricalcium phosphate (b-TCP) provide scaffolds similar to those of autologous bone, are plentiful and inexpensive, and are not associated with donor morbidity. The present report describes the use of Polybone® (Kyungwon Medical, Korea), a beta-tricalcium phosphate, for lumbar posterolateral fusion and assesses clinical and radiological efficacy as a graft material.

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

Comparison of in vitro biocompatibility of NanoBone(®) and BioOss(®) for human osteoblasts. [2016] Scaffolds for bone tissue engineering seeded with the patient's own cells might be used as a preferable method to repair bone defects in the future. With the emerging new technologies of nanostructure design, new synthetic biomaterials are appearing on the market. Such scaffolds must be tested in vitro for their biocompatibility before clinical application. However, the choice between a natural or a synthetic biomaterial might be challenging for the doctor and the patient. In this study, we compared the biocompatibility of a synthetic bone substitute, NanoBone(®) , to the widely used natural bovine bone replacement material BioOss(®) .

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] This systematic review aims to compare clinical evidences related to autologous iliac crest bone graft (ICBG) and non-ICBG (local bone) with allografts and synthetic grafts for spinal fusion procedures in adult and young patients. A systematic search was carried out in three databases (PubMed, Scopus, Web of Science, Cochrane Central Register of Controlled Trials) to identify clinical studies in the last 10 years. The initial search retrieved 1085 studies, of which 24 were recognized eligible for the review. Twelve studies (4 RCTs, 5 prospective, 3 retrospective) were focused on lumbar spine, 9 (2 RCTs, 2 prospective, 4 retrospective, 1 case-series) on cervical spine and 3 (1 RCT, 2 retrospective) on spinal fusion procedures in young patients. Calcium phosphate ceramics, allografts, bioglasses, composites and polymers have been clinically investigated as substitutes of autologous bone in spinal fusion procedures. Of the 24 studies included in this review, only 1 RCT on cervical spine was classified with high level of evidence (Class I) and showed low risk of bias. This RCT demonstrated the safety and efficacy of the proposed treatment, a composite bone substitute, that results in similar and on some metrics superior outcomes compared with local autograft bone. Almost all other studies showed moderately or, more often, high incidence of bias (Class III), thus preventing ultimate conclusion on the hypothesized beneficial effects of allografts and synthetic grafts. This review suggests that users of allografts and synthetic grafting should carefully consider the scientific evidence concerning efficacy and safety of these bone substitutes, in order to select the best option for patient undergoing spinal fusion procedures.

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] Bone substitute biomaterials may be osteogenic, osteoconductive or osteoinductive. To test for these probable characteristics in a new nanoporous grafting material consisting of nanocrystalline hydroxyapatite embedded in a porous silica gel matrix (NanoBone(s)), applied in humans, we studied biopsies from 12 patients before dental implantation following various orofacial augmentation techniques with healing times of between 3.5 and 12 months.