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Bone Graft

Infuse Bone Graft for Spinal Conditions

N/A
Waitlist Available
Led By Chetan Patel
Research Sponsored by Medtronic Spinal and Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS)
Degenerative lumbar spine condition requiring a PLF procedure using a bilateral metallic screw and rod system in 2-4 consecutive levels from L2-S1
Must not have
Significant lumbar instability, defined as sagittal listhesis >Grade 2 at any involved level using Meyerding's Classification or lateral listhesis >25% lateral translation at any involved level
Osteoporosis to a degree that spinal instrumentation is contraindicated or a history of atraumatic vertebral fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device for a common spine surgery, and will help determine the best dose of a protein to use with it for future patients.

Who is the study for?
Adults over 21 with chronic lower back pain from degenerative spinal conditions who haven't improved after 6 months of non-surgical treatments. They must have significant pain and disability, be able to undergo spine fusion surgery at certain levels (L2-S1), and not be pregnant or planning pregnancy for a year post-surgery.
What is being tested?
The trial is testing the safety and effectiveness of Infuse Bone Graft combined with Mastergraft Strip in spine fusion surgery across multiple levels of the lower back. It aims to find the best dose for future studies.
What are the potential side effects?
Potential side effects may include reactions to bone growth proteins, collagen, or surgical materials; infection risks; inflammation; allergic responses; and complications related to bone grafting procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried non-surgical treatments for over 6 months without improvement.
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I need a spine surgery using metal screws and rods from L2 to S1.
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The lowest part of my spine can fit a fusion device.
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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lower back is very unstable, more than what is considered moderate.
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I have severe osteoporosis or a history of spine fractures without injury.
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I plan to use a device to help my bones heal.
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I am not allergic to any study treatment components like BMPs, collagen, or titanium.
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My spine curves more than 30 degrees.
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I currently have cancer or have had cancer in the past.
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I do not have any active bacterial infections.
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I have been treated with specific bone growth proteins.
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I have a condition like Paget's disease that affects bone growth.
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I cannot have surgery due to other health issues.
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I am mentally capable of making my own decisions.
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I have an autoimmune disease that affects my bones or spine.
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I have had a previous surgery to replace a disc in my lower back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 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
Radiological Fusion Success
Secondary study objectives
AEs related to the PLF grafting material or posterior fixation up to 24 months
Back pain score at 12 and 24 months
Back pain success at 12 and 24 months
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3Experimental Treatment1 Intervention
Infuse Bone Graft \[12 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation
Group II: Group 2Experimental Treatment1 Intervention
Infuse Bone Graft \[6 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation
Group III: Group 1Experimental Treatment1 Intervention
Infuse Bone Graft \[4.2 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation
Group IV: ControlActive Control1 Intervention
Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation.

Find a Location

Who is running the clinical trial?

Medtronic Spinal and BiologicsLead Sponsor
55 Previous Clinical Trials
10,488 Total Patients Enrolled
Chetan PatelPrincipal InvestigatorSpine Health Institute
2 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Infuse Bone Graft (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT03118505 — N/A
Degenerative Lumbosacral Spinal Conditions Research Study Groups: Group 1, Group 2, Group 3, Control
Degenerative Lumbosacral Spinal Conditions Clinical Trial 2023: Infuse Bone Graft Highlights & Side Effects. Trial Name: NCT03118505 — N/A
Infuse Bone Graft (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03118505 — N/A
~15 spots leftby Apr 2026
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