Infuse Bone Graft for Spinal Conditions

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Infuse Bone Graft to evaluate its safety and effectiveness for individuals with specific spine issues, such as instability or recurring disc problems. The trial aims to determine the optimal dose of this treatment in multi-level spinal fusion procedures. Participants are divided into groups to test different doses of the graft alongside other materials, with results compared to a standard treatment. This trial may suit individuals who have experienced persistent back problems for over six months and require a specific type of spine surgery.

As an unphased trial, it provides a unique opportunity for patients to contribute to pioneering research in spinal treatment.

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.

What prior data suggests that this investigational device is safe for multi-level PLF procedures?

Research shows that the Infuse Bone Graft is generally safe for spinal fusion surgeries. Past studies have demonstrated its effectiveness in reducing pain and improving outcomes for patients with spinal issues. However, side effects can occur, including swelling, infection, or nerve problems at the surgery site. These risks are common in spinal fusion surgeries and are not unique to this treatment.

The FDA has approved the Infuse Bone Graft for certain spinal procedures, indicating a recognized level of safety. This ongoing trial seeks to gather more information on its use in surgeries involving multiple spine levels and to determine the optimal dose. Although the trial is studying this treatment, its existing approval for other uses provides some reassurance about its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Infuse Bone Graft for spinal conditions because it offers a novel way to promote bone healing. Unlike traditional treatments that often use a patient's own bone (like an iliac crest bone graft) or demineralized bone matrix (DBM), the Infuse Bone Graft utilizes a recombinant human bone morphogenetic protein-2 (rhBMP-2). This protein stimulates the body’s own ability to grow bone, potentially leading to faster and more reliable spinal fusion. Additionally, the study explores varying doses (4.2 mg, 6 mg, and 12 mg per operative level), which could help tailor treatment to individual patient needs. These features might offer improved healing times and outcomes compared to current standards.

What evidence suggests that the Infuse Bone Graft is effective for spinal conditions?

Research has shown that the Infuse Bone Graft is safe and effective for spinal surgeries. In one study, only 0.6% of patients experienced complications, indicating it is a relatively safe choice. Another study found that the Infuse Bone Graft reduced the need for initial and repeat spinal surgeries, demonstrating its effectiveness. This treatment uses a protein called rhBMP-2, which aids the body in growing new bone. Early results suggest it effectively helps bones fuse together, which is crucial for spinal fusion surgeries. Overall, these studies strongly support the potential benefits of the Infuse Bone Graft for treating spinal conditions. Participants in this trial will receive different dosages of the Infuse Bone Graft in various treatment arms, while others will receive the Medtronic DBM as a comparator. ^{1 4 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11346822/

A Narrative Review on Recombinant Human Bone ... Guzman et al. reported reductions in both primary and revision spinal fusion surgeries using rhBMP-2+ACS between quarter 1 of 2010 and quarter 4 ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/p000058b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA The following is a list of potential adverse events which may occur with spinal fusion surgery with the InFUSE™ Bone Graft/LT-CAGE™ Lumbar ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3031052/

Pros, cons, and costs of INFUSE in spinal surgery - PMC Complications directly attributed to INFUSE occurred in 6 (0.6%) patients. Although they concluded that INFUSE was relatively safe and effective ...

4. bmj.com bmj.com/content/346/bmj.f3981

Reporting of industry funded study outcome data For individual randomised controlled trials, 56% (9/16) to 88% (15/17) of effectiveness outcomes known to have been collected were reported in ...

5. news.medtronic.com news.medtronic.com/Medtronic-achieves-major-milestone-in-INFUSE-TM-Bone-Graft-for-TLIF-Study,-paving-the-way-for-new-spine-procedure-indication

Medtronic achieves major milestone in INFUSE™ Bone ... The study is designed to evaluate the safety and effectiveness of INFUSE™ Bone Graft in TLIF procedures for patients with degenerative lumbar ...

6. medtronic.com medtronic.com/en-us/l/isw/infuse-bone-graft-indications-safety-warnings.html

Infuse Bone Graft - Indications, Safety, and Warnings The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12438990/

Clinical and radiographic outcomes of anterior lumbar ... The use of InFUSE Bone Graft is a promising method of facilitating anterior intervertebral spinal fusion, decreasing pain, and improving clinical outcomes.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01415908

INFUSE®Bone Graft in Transforaminal Lumbar Interbody ... This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® ...