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

Primary Purpose

Degenerative Disc Disease, Spondylolisthesis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NanoBone

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Nanotechnology, NanoBone, Spine Fusion, Bone Graft

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
Patients less than 18 years old

Sites / Locations

UMass Memorial Health CareRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm subject is own control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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

Change from pre-operative score

Secondary Outcome Measures

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

Change from pre-operative score

SF-36 (Short Form 36)

Change from pre-operative score

Full Information

NCT ID

NCT04615260

First Posted

October 29, 2020

Last Updated

February 10, 2023

Sponsor

Artoss Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04615260

Brief Title

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

Acronym

BONE

Official Title

Comparison of Fusion Success Between NanoBone Synthetic Bone Graft and Local Autogenous Bone Graft in Posterolateral Spinal Fusion

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 19, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Artoss Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disc Disease, Spondylolisthesis

Keywords

Nanotechnology, NanoBone, Spine Fusion, Bone Graft

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm subject is own control

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

NanoBone

Other Intervention Name(s)

NanoHA (SiO2)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Radiographic Fusion

Description

Time Frame

12 months

Title

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

Description

Change from pre-operative score

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Change from pre-operative score

Time Frame

12 months

Title

SF-36 (Short Form 36)

Description

Change from pre-operative score

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 Patients less than 18 years old

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Saharsh Mehta

Phone

(508) 334-9761

Saharsh.Mehta@umassmemorial.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jim Cassidy, Ph.D..

jcassidy@artossinc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Connelly, MD

Organizational Affiliation

UMass Memorial Health Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

UMass Memorial Health Care

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick Connelly, MD

First Name & Middle Initial & Last Name & Degree

Michael Stauff, MD

12. IPD Sharing Statement

Learn more about this trial

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

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