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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

BONE Trial 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.Check my eligibility

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.See study design

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.

BONE Trial 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.

BONE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Radiographic Fusion

Secondary outcome measures

SF-36 (Short Form 36)

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

BONE 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Artoss Inc.Lead Sponsor

3 Previous Clinical Trials

730 Total Patients Enrolled

Patrick Connelly, MDPrincipal InvestigatorUMass Memorial Health Care

Media Library

NanoBone (Synthetic Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04615260 — N/A

Spondylolisthesis Research Study Groups: Single arm subject is own control

Spondylolisthesis Clinical Trial 2023: NanoBone Highlights & Side Effects. Trial Name: NCT04615260 — N/A

NanoBone (Synthetic Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04615260 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially join this research initiative?

"This medical trial is in need of 40 individuals between the ages 18 and 85 that have been diagnosed with intervertebral disc degeneration. To meet the requirements, participants must satisfy further criteria such as having 1 or 2 level DDD/spondylolisthesis grade 1-3 with or without spinal stenosis necessitating posterolateral fusion surgery with bone grafting, being skeletally mature, and falling within the specified age range."

Answered by AI

Is eligibility for this experiment open to individuals aged 45 and above?

"This medical experiment is open to all individuals aged 18 or above and 85 or below."

Answered by AI

Is enrollment to this study open for participants at present?

"Per clinicaltrials.gov, this research endeavour is still open for participants and has been since July 19th 2021. The details were most recently revised on the 20th of that same month."

Answered by AI

How many individuals are actively engaging in this medical evaluation?

"Affirmative. Clinicaltrials.gov records indicate that the enrollment process for this medical trial began on July 19th 2021 and is still ongoing at present time. 40 individuals are needed to participate in the experiment, which will be held at one site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04615260.

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