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Bone Graft
Infuse Bone Graft for Spinal Conditions
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
The lowest part of my spine can fit a fusion device.
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I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiological Fusion Success
Secondary outcome measures
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lower back is very unstable, more than what is considered moderate.I have tried non-surgical treatments for over 6 months without improvement.I have severe osteoporosis or a history of spine fractures without injury.I plan to use a device to help my bones heal.I am not allergic to any study treatment components like BMPs, collagen, or titanium.You have had severe allergic reactions in the past that caused a dangerous condition called anaphylaxis.I haven't been part of a clinical trial for a new treatment in the last 30 days and don't plan to join one within the next 24 months.I need a spine surgery using metal screws and rods from L2 to S1.My spine curves more than 30 degrees.I currently have cancer or have had cancer in the past.I do not have any active bacterial infections.I have been treated with specific bone growth proteins.The lowest part of my spine can fit a fusion device.Your preoperative ODI score is 40 or higher.I am 21 years old or older.I have a condition like Paget's disease that affects bone growth.I cannot have surgery due to other health issues.I am mentally capable of making my own decisions.I haven't taken steroids, cancer drugs, or immune system medications in the last 30 days.I have had spinal fusion surgery at or near the area of my current back problem.I have a diagnosed spine condition, including mild slippage or narrowing.I have an autoimmune disease that affects my bones or spine.You have severe pain in your leg before surgery, scoring 8 or higher on a pain questionnaire.I have had a previous surgery to replace a disc in my lower back.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
- Group 4: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have taken part in this research initiative?
"The trial sponsor, Medtronic Spinal and Biologics, needs 125 participants that meet the study's criteria to commence. The clinical trials will take place at two locations - University of California, Davis in Sacramento and The Spine Health Institute in Altamonte Springs, Michigan."
Answered by AI
Can any individuals participate in this research endeavor?
"The data collected on clinicaltrials.gov confirms that recruitment for this medical trial is in progress, having been first posted on June 29th 2017 and last updated September 10th 2021."
Answered by AI
How many healthcare facilities have been participating in this trial?
"Patients are currently being recruited by 7 different medical centres. These locations include Sacramento, Altamonte Springs and Kalamazoo among others, allowing potential study participants to select the closest centre in order to reduce any travelling difficulties that may arise from participating."
Answered by AI
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