Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft.

NCT04615260 | Active Not Recruiting DMC FDA Device

• 1 other identifier: H0015310
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis

Keywords

Nanotechnology; NanoBone; Spine Fusion; Bone Graft

Outcome Measures

Primary Outcomes (2)

• Radiographic Fusion

  Fusion will be defined as: * Evidence of bridging trabecular bone between the transverse processes of the involved vertebral bodies * Translational motion \< 3.5mm on flexion/extension radiographs; and * Angular motion \<5 degrees on flexion/extension radiographs.

  12 months

• Oswestry Disability Index (ODI) 0% lowest, no disability to 100% disabled, bedridden

  Change from pre-operative score

  12 months

Secondary Outcomes (2)

• Visual Analog Scale (VAS) 0-no pain to 10-worst possible pain

  12 months

• SF-36 (Short Form 36)

  12 months

Study Arms (1)

Single arm subject is own control

OTHER

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.

Device: NanoBone

Interventions

NanoBone DEVICE

Nanobone® Synthetic Bone Graft is a nanocrystalline hydroxyapatite imbedded in a silica gel matrix. The nanocrystalline structure accurately replicates autologous hydroxyapatite and the silica gel matrix that rapidly transforms into an osteogenic matrix post-implantation. NanoBone promotes remodeling by acting as a strong osteoinductive material. NanoBone® is available as a putty.

Also known as: NanoHA (SiO2)

Single arm subject is own control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
• The individual is 18 to 85 years of age.
• The individual is skeletally mature.
• The individual has been diagnosed with 1 or 2 level degenerative disc disease or spondylolisthesis grade 1-3 with or without spinal stenosis, requiring posterolateral spinal fusion surgery with bone grafting.
• The individual is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

• The individual has had any previous attempts at fusion, at any lumbar levels.
• The individual is morbidly obese (defined as 100 lbs over the recommended ideal weight as described in the Metropolitan Life Height and Weight Tables for Men and Women and or having a BMI \>39).
• Patients with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
• Patients with systemic collagen, bone or mineralization dysfunction (such as Paget's disease, osteogenesis imperfecta, Ehlers-Danlos Syndrome).
• Patients who suffer from uncontrolled diabetes mellitus type I or insulin-dependent diabetes mellitus type II. (definition based on the glycosylated Haemoglobin level)
• Patients who are suffering from autoimmune disease.
• Patients who previously underwent chemotherapy, immunosuppressive disease or radiation to the local area.
• Patients who received or are currently receiving corticosteroids (\> 2 years \> 5 mg prednisolone equivalent/d).
• Patients with active local or systemic infection.
• Patients with any known active malignancy.
• Patients with other concurrent physical or mental conditions which are likely to affect their outcome.
• Patient unable to consent for themselves
• Pregnant women
• 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.
• Prisoners

Sponsors & Collaborators

• Artoss Inc.: lead

Study Sites (1)

UMass Memorial Health Care

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Patrick Connelly, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study is a prospective, non-randomized, single center clinical investigation. 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.

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: July 19, 2021
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

US (1)