Infuse™ Bone Graft for Spinal Fusion

(TLIF Trial)

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medtronic Spinal and Biologics

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

Disqualifiers: Osteoporosis, Malignancy, Autoimmune disease, others

No Placebo Group

Approved in 6 Jurisdictions

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}

Research Team

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.

Trial 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 (Bone Graft)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical College of Wisconsin Milwaukee, WI

Houston Methodist Hospital Houston, TX

Tennessee Orthopaedic Alliance Nashville, TN

DFW Center for Spinal Disorder Fort Worth, TX

More Trial Locations

Who Is Running the Clinical Trial?

Medtronic Spinal and Biologics

Lead Sponsor

Trials

56

Patients Recruited

10,600+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]