Trial Summary
What is the purpose of this trial?
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
Research Team
CP
Chetan Patel, MD
Principal Investigator
Spine Health Institute
Eligibility Criteria
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.Inclusion Criteria
I have tried non-surgical treatments for over 6 months without improvement.
I need a spine surgery using metal screws and rods from L2 to S1.
The lowest part of my spine can fit a fusion device.
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Exclusion Criteria
Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for one year following surgery
My lower back is very unstable, more than what is considered moderate.
I have severe osteoporosis or a history of spine fractures without injury.
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Treatment Details
Interventions
- Infuse Bone Graft (Bone Graft)
- Medtronic DBM (Bone Graft)
Trial OverviewThe 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.
Participant Groups
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.
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Who Is Running the Clinical Trial?
Medtronic Spinal and Biologics
Lead Sponsor
Trials
56
Recruited
10,600+