Infuse™ Bone Graft for Spinal Fusion

(TLIF Trial)

Recruiting at 34 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

1017 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. Overall a maximum of 1017 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in A Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.

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 data supports the effectiveness of the Infuse™ Bone Graft for Spinal Fusion treatment?

Research shows that transforaminal lumbar interbody fusion (TLIF), a type of spinal surgery, is effective for various spine conditions like lumbar spondylolisthesis (a condition where a vertebra slips out of place) and disc herniation (when a disc in the spine bulges out). This suggests that the Infuse™ Bone Graft, used in TLIF, may also be effective in helping the spine heal and fuse properly. ^{1 2 3 4 5}

Is the Infuse™ Bone Graft for Spinal Fusion generally safe for humans?

The transforaminal lumbar interbody fusion (TLIF) procedure, which may use the Infuse™ Bone Graft, has been studied for safety. Some studies report concerns about complications and longer surgery times, but it is a common method for spinal fusion. Always discuss potential risks with your doctor. ^{3 6 7 8 9}

How is the Infuse™ Bone Graft treatment for spinal fusion different from other treatments?

Infuse™ Bone Graft is unique because it uses bone morphogenetic protein-2 (a protein that helps bone growth) combined with a special collagen carrier to promote spinal fusion, unlike traditional methods that often use bone taken from the patient's own body. This approach can potentially reduce the need for additional surgery to harvest bone, which can decrease pain and recovery time. ^{5 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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 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]

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 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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

[The anatomic study and clinical significance of the modified transforaminal lumbar interbody fusion]. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of transforaminal lumbar interbody fusion in the treatment of double-level lumbar spondylolisthesis with sagittal imbalance. [2022]

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

Morphologic Changes in Contralateral Lumbar Foramen in Unilateral Cantilever Transforaminal Lumbar Interbody Fusion Using Kidney-type Intervertebral Spacers. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Transforaminal lumbar interbody fusion in treatment of upper lumbar disc herniation: analysis of 18 cases]. [2011]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. China 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. [2022]

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

Complications associated with single-level transforaminal lumbar interbody fusion. [2022]

8. England 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. [2022]

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

Perioperative surgical complications of transforaminal lumbar interbody fusion: a single-center experience. [2022]

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

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

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

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

12. Netherlands pubmed.ncbi.nlm.nih.gov

Transforaminal lumbar interbody fusion rates in patients using a novel titanium implant and demineralized cancellous allograft bone sponge. [2022]

13. Germany 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. [2019]