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

Last updated: February 11, 2025
Sponsor: Artoss Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Spondylolisthesis

Ankylosing Spondylitis

Treatment

NanoBone

Clinical Study ID

NCT04615260
H0015310
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The individual has signed and dated a study specific informed consent form approvedby the Institutional Review Board at UMMHC.

  2. The individual is 18 to 85 years of age.

  3. The individual is skeletally mature.

  4. The individual has been diagnosed with 1 or 2 level degenerative disc disease orspondylolisthesis grade 1-3 with or without spinal stenosis, requiringposterolateral spinal fusion surgery with bone grafting.

  5. The individual is physically and mentally willing and able to comply with thepostoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion

Exclusion Criteria:

  1. The individual has had any previous attempts at fusion, at any lumbar levels.

  2. The individual is morbidly obese (defined as 100 lbs over the recommended idealweight as described in the Metropolitan Life Height and Weight Tables for Men andWomen and or having a BMI >39).

  3. Patients with osteopenia, osteoporosis, or osteomalacia to a degree that spinalinstrumentation would be contraindicated.

  4. Patients with systemic collagen, bone or mineralization dysfunction (such as Paget'sdisease, osteogenesis imperfecta, Ehlers-Danlos Syndrome).

  5. Patients who suffer from uncontrolled diabetes mellitus type I or insulin-dependentdiabetes mellitus type II. (definition based on the glycosylated Haemoglobin level)

  6. Patients who are suffering from autoimmune disease.

  7. Patients who previously underwent chemotherapy, immunosuppressive disease orradiation to the local area.

  8. Patients who received or are currently receiving corticosteroids (> 2 years > 5 mgprednisolone equivalent/d).

  9. Patients with active local or systemic infection.

  10. Patients with any known active malignancy.

  11. Patients with other concurrent physical or mental conditions which are likely toaffect their outcome.

  12. Patient unable to consent for themselves

  13. Pregnant women

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

  15. Prisoners

  16. Patients less than 18 years old

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: NanoBone
Phase:
Study Start date:
July 19, 2021
Estimated Completion Date:
April 30, 2025

Study Description

Subjects will be recruited for this study from among those scheduled to undergo 1-2 level posterolateral spinal fusion procedures with bone grafting for degenerative disc disease or grade 1-3 spondylolisthesis. The study will entail each subject having a local bone graft placed on the left side of their spine, with Nanobone placed on the right side of their spine during the procedure. Eligible and consenting patients recruited for this study will be subject to the standard of care. This includes the following visits: preoperative, operative, post-discharge, 4 months postoperative, 1-year postoperative, and 2-years postoperative. They will be subject to standard of care imaging modalities including AP, lateral, and flexion/extension lumbar radiographs at pre-operative, post-discharge, 4-months postoperative, 1-year postoperative, and 2-year postoperative time points. Standard of care advanced imaging including a CT scan or magnetic resonance imaging (MRI) scan will be performed pre-operatively. Patients will also receive standard of care clinical examinations and self-assessments at all clinic visits. Imaging obtained outside the standard of care for this study will include 1-year and 2-year lumbar CT scans to evaluate fusion. The 2-year lumbar CT scan will only be required if fusion has not been demonstrated at the time of the 1-year lumbar CT scan. Patients enrolled in this study who are treated with rigid pedicle screw fixation must be treated using rigid pedicle screw instrumentation appropriate for posterolateral spinal fusions.

Connect with a study center

  • UMass Memorial Health Care

    Worcester, Massachusetts 01605
    United States

    Site Not Available

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