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Synthetic Bone Graft

NanoBone® Synthetic Bone Graft for Spinal Fusion (BONE Trial)

N/A

Recruiting

Led By Patrick Connelly, MD

Research Sponsored by Artoss Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The individual is 18 to 85 years of age.

The individual is skeletally mature.

Must not have

Patients with any known active malignancy.

Patients who are suffering from autoimmune disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a synthetic bone graft is as effective as a local bone graft in creating a fusion in the lumbar spine.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for NanoBone®, typical risks may include pain at the graft site, inflammation, infection risk increase due to surgery and possible reaction to synthetic materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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My bones have stopped growing.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active cancer.

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I have an autoimmune disease.

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I am under 18 years old.

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My diabetes is not well-controlled.

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I have had chemotherapy, immunosuppressive treatment, or radiation before.

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I have a condition affecting my body's collagen, bones, or mineralization.

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I have been taking corticosteroids equivalent to more than 5 mg of prednisolone daily for over 2 years.

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I am unable to give consent for my own medical treatment.

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I have had spinal fusion surgery in the past.

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I am more than 100 lbs over my ideal weight or my BMI is over 39.

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I currently have an infection.

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I have bone conditions that prevent spinal surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Radiographic Fusion

Secondary study objectives

SF-36 (Short Form 36)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm subject is own controlExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NanoBone

2012

N/A

~20

0 / 15Eligibility criteria met