Infuse Bone Graft for Spinal Conditions

Recruiting at 17 trial locations

Overseen By Lauren Oien, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Spinal and Biologics

Must not be taking: Corticosteroids, Antineoplastics, Immunosuppressives, others

Disqualifiers: Prior spinal fusion, Malignancy, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken corticosteroids, anti-cancer drugs, or immune-related drugs within 30 days before the procedure.

Is the Infuse Bone Graft safe for use in humans?

The Infuse Bone Graft, also known as rhBMP-2, has been studied for spinal fusion and has shown some adverse events, but these are not uncommon compared to other bone graft options. However, the data is varied, and more rigorous studies are needed to fully understand its safety profile. ^{1 2 3 4 5}

How is the Infuse Bone Graft treatment different from other spinal condition treatments?

The Infuse Bone Graft is unique because it uses a special protein called recombinant human bone morphogenetic protein-2 (rhBMP-2) to encourage the body to grow new bone, reducing the need for bone taken from other parts of the body. It involves a collagen sponge soaked with this protein, which is placed in the spine to help with bone fusion, allowing for a quicker recovery compared to traditional methods. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Infuse Bone Graft for spinal conditions?

Research shows that the Infuse Bone Graft, which includes a protein called rhBMP-2, is effective for helping bones in the spine fuse together, especially in older patients. Studies have found it works well compared to traditional bone grafts taken from the hip bone. ^{1 11 12 13 14}

Who Is on the Research Team?

Chetan Patel, MD

Principal Investigator

Spine Health Institute

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Infuse Bone Graft with Mastergraft Strip and posterior fixation for multi-level PLF procedures

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiological fusion success and pain assessments

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Infuse Bone Graft
• Medtronic DBM

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

Infuse Bone Graft \[12 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation

Group II: Group 2 Experimental Treatment 1 Intervention

Infuse Bone Graft \[6 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation

Group III: Group 1 Experimental Treatment 1 Intervention

Infuse Bone Graft \[4.2 mg per operative level\] + Mastergraft Strip + local bone autograft + posterior fixation

Group IV: Control Active Control 1 Intervention

Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation.

Who Is Running the Clinical Trial?

Medtronic Spinal and Biologics

Lead Sponsor

Trials

56

Recruited

10,600+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Instrumented one and two level posterolateral fusions with recombinant human bone morphogenetic protein-2 and allograft: a computed tomography study. [2016]

3. China pubmed.ncbi.nlm.nih.gov

[Clinical study of lumbar fusion by hybrid construct of stem cells technique and biodegradable material]. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of different bone graft fusion ways in treating thoracolumbar burst fractures]. [2012]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of fusion rate enhancements and bone graft options for spine surgery. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Use of cortical cancellous allograft for posterior spinal fusion. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The safe and effective use of supercritical CO2-processed bone allografts for cervical and lumbar interbody fusion: A retrospective study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

High-dose bone morphogenetic protein-induced ectopic abdomen bone growth. [2011]

11. United States pubmed.ncbi.nlm.nih.gov

Case report: Tuberculosis recall on bone graft patient. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Creation and preclinical evaluation of a novel mussel-inspired, biomimetic, bioactive bone graft scaffold: direct comparison with Infuse bone graft using a rat model of spinal fusion. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Freeze-dried cortical allograft in posterior spinal arthrodesis: use with segmental instrumentation for idiopathic adolescent scoliosis. [2022]

14. New Zealand pubmed.ncbi.nlm.nih.gov

BMP 2--Genetics Institute/ Medtronic-Sofamor Danek/Integra. Bone morphogenetic protein 2--Genetics Institute/ Medtronic-Sofamor Danek/Integra, INFUSE Bone Graft, recombinant human bone morphogenetic protein 2--Genetics Institute/Medtronic-Sofamor Danek/Integra, RhBMP 2--Genetics Institute/Medtronic-Sofamor Danek/Integra. [2018]