Infuse™ Bone Graft for Spinal Fusion

(TLIF Trial)

Not currently recruiting at 46 trial locations

Overseen By Selby Chen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Spinal and Biologics

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

Disqualifiers: Osteoporosis, Malignancy, Autoimmune disease, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: Surgery and immediate postoperative care

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of Infuse™, a bone graft treatment, for individuals needing spinal fusion surgery in the lower back (lumbosacral spine). The researchers aim to determine if Infuse™ outperforms the current standard treatment for spinal fusion procedures. Participants will receive either the Infuse™ treatment or a standard bone graft to compare outcomes. Suitable candidates have experienced back pain, radiating leg pain, or nerve issues from spinal degeneration and have not improved with other treatments for six months. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future spinal fusion treatments.

Will I have to stop taking my current medications?

The trial requires that participants stop taking certain medications, such as corticosteroids, antineoplastic, immunostimulating, or immunosuppressive agents, within 30 days before treatment. If you are taking warfarin, you need to stop at least 5 days before treatment. Short-term steroid use is allowed, but long-term use is not permitted during the study.

What prior data suggests that Infuse™ Bone Graft is safe for spinal fusion procedures?

Research has shown that Infuse™ Bone Graft has been safely used in various back surgeries. In past studies, patients generally tolerated Infuse™ well when used for spinal fusion. Some possible side effects, such as swelling, infection, or nerve damage, have been reported, but these risks are similar to those of other bone graft surgeries. The FDA has already approved Infuse™ for certain back surgeries, indicating it has met safety standards for those uses. This trial aims to gather more information on its safety in a specific back surgery called Transforaminal Lumbar Interbody Fusion (TLIF). ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional spinal fusion treatments that primarily rely on local bone autografts, the investigational Infuse™ Bone Graft introduces a synthetic protein, BMP-2 (Bone Morphogenetic Protein-2), to enhance bone growth and fusion. Researchers are excited about Infuse™ because it may potentially improve fusion rates and promote faster healing by actively stimulating bone formation. Additionally, with options of 2.1 mg/level and 4.2 mg/level doses, Infuse™ offers flexibility in treatment, which could be tailored to the specific needs of the patient, potentially improving outcomes over the current standard of care.

What evidence suggests that this trial's treatments could be effective for spinal fusion?

Studies have shown that the Infuse™ Bone Graft effectively aids bone fusion in spinal surgeries. In this trial, participants in Group #1 will receive the investigational Infuse™ 2.1 mg/level, while those in Group #2 will receive the investigational Infuse™ 4.2 mg/level. Research indicates that patients using Infuse™ often experience successful bone fusion and less pain compared to traditional methods. This treatment employs a special protein that promotes bone growth, facilitating bone connection. Early findings suggest it might relieve symptoms more effectively than current treatments. Overall, the Infuse™ Bone Graft appears to be a promising option for spinal fusion procedures. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with degenerative spine disease causing back pain, leg or buttock pain, numbness, or weakness. They must have tried non-surgical treatments for six months without success and have certain levels of disability and pain. Excluded are those with previous major spine surgeries, severe osteoporosis, morbid obesity, active cancer, infections, metabolic disorders affecting bone growth, allergies to study materials, mental incompetence, substance abuse issues or other conditions that might affect results.

Inclusion Criteria

My back pain score is at least 1 and my leg pain score is 4 or more.

I have a history of low back pain.

Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.

Exclusion Criteria

You have a history of severe allergic reactions that can be life-threatening.

Pursuing worker's compensation or active litigation for spinal fusion procedure.

My lower back is significantly unstable, as confirmed by specific spine tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Clinical and radiological evaluation performed preoperatively

1-2 weeks

Treatment

Participants undergo Transforaminal Lumbar Interbody Fusion (TLIF) with Infuse™ Bone Graft

Surgery and immediate postoperative care

Postoperative Follow-up

Participants are monitored for safety and effectiveness, including clinical and radiological evaluations

24 months

Regular visits up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• TLIF

Trial Overview The trial tests the safety and effectiveness of Infuse™ Bone Graft in spinal fusion surgery (TLIF) on patients with lumbosacral spine disease. It's a global study where participants will be randomly assigned to receive either the new treatment or a control intervention and monitored over 24 months postoperatively.

How Is the Trial Designed?

Group I: Group #2 Experimental Treatment 2 Interventions

Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed

Group II: Group #1 Experimental Treatment 2 Interventions

Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed

Group III: Control Active Control 1 Intervention

Local bone autograft and supplemented with cancellous allograft as needed.

TLIF is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Recurrent disc herniations
• Pseudoarthrosis

Approved in European Union as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Recurrent disc herniations
• Pseudoarthrosis

Approved in Canada as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Recurrent disc herniations
• Pseudoarthrosis

Approved in Japan as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Recurrent disc herniations
• Pseudoarthrosis

Approved in China as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Recurrent disc herniations
• Pseudoarthrosis

Approved in Switzerland as TLIF for:

• Degenerative disc disease
• Spondylolisthesis
• Spinal stenosis
• Recurrent disc herniations
• Pseudoarthrosis

Who Is Running the Clinical Trial?

Medtronic Spinal and Biologics

Lead Sponsor

Trials

56

Recruited

10,600+

Published Research Related to This Trial

In a study of 23 patients undergoing transforaminal lumbar interbody fusion (TLIF) with local bone graft for single-level isthmic spondylolisthesis, significant improvements were observed in pain and function, with VAS scores decreasing from 8.48 to 2.91 and Denis Work Scale scores improving from 4.67 to 1.33 after an average follow-up of 28 months.

The procedure resulted in a high rate of definitive union in 18 out of 23 patients, indicating that TLIF with local bone graft is an effective treatment for this condition, although it is not recommended for cases with more than 25% anterior vertebral translation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transforaminal Lumbar Interbody Fusion With Local Bone Graft Alone for Single-Level Isthmic Spondylolisthesis. Sleem, A., Marzouk, A.[2022]

Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is associated with significantly less intra-operative blood loss and shorter postoperative hospital stays compared to open TLIF, making it a safer option for patients.

Both MI-TLIF and open TLIF effectively reduce pain and improve function in patients with single segmental lumbar spondylolisthesis, but MI-TLIF offers these benefits with fewer complications and a quicker recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of minimally invasive and open transforaminal lumbar interbody fusion in the treatment of single segmental lumbar spondylolisthesis: minimum two-year follow up. Wu, AM., Hu, ZC., Li, XB., et al.[2022]

In 2010, a study at one institution found that 96% of spinal fusions using INFUSE were performed off-label, resulting in a total cost of approximately $4.5 million, while only 4% were on-label, costing about $296,000.

The significant majority of INFUSE usage was off-label, raising concerns about the implications for safety and efficacy, as the FDA only approves it for specific uses in spinal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs and frequency of "off-label" use of INFUSE for spinal fusions at one institution in 2010. Epstein, NE., Schwall, GS.[2022]

In a study of 130 patients undergoing single-level TLIF, the complication rate was 33.6%, with the autograft group experiencing a higher rate of complications (45.5%) compared to the rhBMP-2 group (29.1%), although this difference was not statistically significant.

The use of a hydrogel sealant in the rhBMP-2 group significantly reduced the incidence of postoperative radiculitis from 20.4% to 5.4%, highlighting a potential strategy to improve safety in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with single-level transforaminal lumbar interbody fusion. Rihn, JA., Patel, R., Makda, J., et al.[2022]

The novel minimally invasive surgery (MIS) bone graft delivery device significantly increased the amount of bone graft delivered (6.7 mL) compared to the conventional system (2.3 mL), indicating improved efficacy in the procedure.

Patients using the MIS device experienced shorter operative times and higher rates of complete bone fusion (39.5% vs. 3.5% in the conventional group) after 3 months, suggesting enhanced safety and effectiveness of the new device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel surgical technique in transforaminal lumbar interbody fusion by the bone graft delivery device: evaluation of therapeutic effect in patients with minimally invasive spine surgery. Yang, KS., Chen, CW., Yau, RB., et al.[2022]

In a study of 58 patients undergoing cantilever transforaminal lumbar interbody fusion (c-TLIF), significant increases in lumbar foraminal dimensions were observed on the side opposite to where the spacer was inserted, indicating potential indirect decompression of the contralateral nerve root.

The increase in posterior disk height positively correlated with the enlargement of foraminal dimensions, while an increase in sagittal disk angle negatively correlated with these changes, suggesting that maintaining proper spinal alignment is crucial for optimizing foraminal size post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphologic Changes in Contralateral Lumbar Foramen in Unilateral Cantilever Transforaminal Lumbar Interbody Fusion Using Kidney-type Intervertebral Spacers. Iwata, T., Miyamoto, K., Hioki, A., et al.[2022]

In a study of 40 patients undergoing minimally invasive transforaminal lumbar interbody fusion (MI-TLIF), using local bone autograft drill shavings resulted in a fusion rate of 67.5%, demonstrating its potential as an effective graft option.

The clinical outcomes were positive, with 92% of patients reporting excellent or good results based on improvements in disability and pain scores, regardless of whether fusion was achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic outcomes using local bone shavings as autograft in minimally invasive transforaminal lumbar interbody fusion. Kasliwal, MK., Deutsch, H.[2022]

In a study of 82 patients undergoing transforaminal lumbar interbody fusion (TLIF), the use of an acid-etched, roughened titanium cage with demineralized bone graft achieved high fusion rates of 93.2% at 6 months and 97.4% at 12 months.

This method demonstrated similar fusion rates to traditional options like iliac crest bone graft and recombinant bone morphogenetic protein, but with no reported device-related complications, suggesting a safer alternative with potentially lower morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transforaminal lumbar interbody fusion rates in patients using a novel titanium implant and demineralized cancellous allograft bone sponge. Girasole, G., Muro, G., Mintz, A., et al.[2022]

In a study of 531 patients undergoing transforaminal lumbar interbody fusion (TLIF), 25.4% experienced at least one procedure-related complication, with durotomy (14.3%) and infection (3.8%) being the most common.

Patients with a history of previous lumbar surgery and those undergoing multilevel fusions had significantly higher complication rates, indicating that these factors may increase the risk of adverse outcomes during TLIF procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative surgical complications of transforaminal lumbar interbody fusion: a single-center experience. Tormenti, MJ., Maserati, MB., Bonfield, CM., et al.[2022]

Transforaminal lumbar interbody fusion (TLIF) is effective in treating continuous double-level lumbar spondylolisthesis, significantly improving pain and disability scores in 36 patients, as measured by VAS, JOA, and ODI after surgery.

The procedure successfully restored lumbar lordosis and corrected sagittal spinal alignment, indicating its efficacy in addressing both symptoms and underlying spinal deformities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of transforaminal lumbar interbody fusion in the treatment of double-level lumbar spondylolisthesis with sagittal imbalance. Luan, H., Wang, Y., Liu, K., et al.[2022]

The modified transforaminal lumbar interbody fusion (TLIF) technique, tested on 12 fresh cadavers, shows promise in reducing the risk of nerve root injuries compared to traditional methods by preserving key anatomical structures during surgery.

This new approach allows for effective decompression of the central canal and nerve root canal while minimizing trauma to surrounding tissues, making it a potentially safer option for patients undergoing lumbar fusion surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The anatomic study and clinical significance of the modified transforaminal lumbar interbody fusion]. Jiang, JY., Ma, X., Lü, FZ., et al.[2009]

Transforaminal lumbar interbody fusion (TLIF) is an effective surgical treatment for upper lumbar disc herniation, with excellent or good outcomes in 15 out of 18 patients after an average follow-up of 19.8 months.

The procedure successfully restored disc spaces and lumbar curvature without any serious complications, such as spinal cord or nerve root injuries, indicating its safety and efficacy for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transforaminal lumbar interbody fusion in treatment of upper lumbar disc herniation: analysis of 18 cases]. Liu, HY., Wang, B., Wang, HM., et al.[2011]

In a study of 33 patients undergoing modified transforaminal lumbar interbody fusion (TLIF), interbody fusion cages were found to better preserve intervertebral space and foramen height, making them more suitable for young adults.

Autologous bone grafts achieved faster bony fusion compared to interbody cages, suggesting they are a better option for middle-aged and elderly patients undergoing the same procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the early efficacies of autologous bone grafting and interbody fusion cages for treating degenerative lumbar instability in patients of different ages. Zhong, HZ., Tian, DS., Zhou, Y., et al.[2019]

Citations

1. 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® ...

2. 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 INFUSE™ Bone Graft for TLIF study is a prospective, multicenter, randomized controlled trial conducted under an IDE. The study is designed ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8369686/

Lumbar spine fusion outcomes using a cellular bone ... The results of this study suggest that V-CBA consistently yields successful fusion and significant decreases in patient-reported ODI and VAS.

4. 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 ...

5. studypages.com studypages.com/s/a-study-of-the-infuse-bone-graft-for-transforaminal-lumbar-interbody-fusion-tlif-181186/

A Study of the Infuse Bone Graft for Transforaminal ... This study is designed to test if relief of symptoms provided by the Infuse Bone Graft construct is better, worse, or the same as the current treatment ...

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

Infuse Bone Graft - Indications, Safety, and Warnings SPINAL INDICATIONS. BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR: Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12430733/

Efficacy and Safety of Osteobiologics for Lumbar Spinal ... The use of osteobiologics to enhance fusion has emerged as a promising alternative to address the limitations of autologous iliac crest bone ...

8. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/3/6/article-p436.xml

Safety of transforaminal lumbar interbody fusion and ... Although all data were collected prospectively, this is a retrospective clinical study in which we evaluate data obtained between October 2002 and December 2003 ...