Lumbar Interbody Fusion for Lumbar Spine Degeneration

(3STLIF Trial)

Not currently recruiting at 24 trial locations

Overseen By Kevin McGinnis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 3Spine

Must not be taking: Immunosuppressants, Biologics

Disqualifiers: Diabetes, Osteopenia, Autoimmune, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial gathers real-world data on the safety and effectiveness of lumbar fusion surgery using specific techniques and tools. It focuses on individuals with lumbar degeneration, a condition that causes back pain and other issues due to wear and tear in the lower spine. Participants should already plan to undergo single-level lumbar fusion surgery and have tried other treatments, such as physical therapy, without success. The study aims to improve understanding and outcomes of these surgeries. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on any drugs that might interfere with bone or soft tissue healing, you may need to stop them. It's best to discuss your specific medications with the trial team.

What prior data suggests that this technique is safe for lumbar interbody fusion?

Research has shown that transforaminal lumbar interbody fusion (TLIF) is generally safe and effective. One study found that TLIF leads to good results for patients, even for those with previous back surgeries. Another large study discovered that performing this surgery in an outpatient setting, where patients go home the same day, is safe and might actually result in fewer complications compared to hospital stays.

For posterior lumbar interbody fusion (PLIF), studies have shown that patients experience improvements after surgery, such as reduced back pain and better movement. While there are some risks, as with any surgery, these procedures are usually well-tolerated.

Both TLIF and PLIF have been used in medical practice for a long time, which helps doctors perform them safely. It is always important to talk with a healthcare provider to understand personal risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lumbar interbody fusion techniques under study, particularly Lumbar Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF/PLIF), because they offer a targeted approach to spinal stability. Unlike standard treatments, which may involve more invasive procedures, these techniques use specialized implants to maintain disc height and alignment, potentially reducing recovery time and improving outcomes. Additionally, the use of pedicle screws in stabilizing the spine provides a robust support system that can enhance patient mobility and alleviate pain more effectively. This combination of precision and support makes these treatments a promising option for those undergoing surgery for lumbar spine issues.

What evidence suggests that Lumbar Interbody Fusion might be an effective treatment for patients undergoing TLIF or PLIF?

Research has shown that lumbar interbody fusion, including types like TLIF and PLIF, effectively treats spinal issues. Studies indicate that spinal fusion, such as TLIF, achieves high success rates, with fusion rates between 95% and 97.7% two years post-surgery. Patients undergoing lumbar fusion often experience less pain and improved quality of life compared to those opting for non-surgical treatments. Overall, these procedures have successfully improved spinal stability and reduced pain for many individuals. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is to be treated with on-label use of an FDA-cleared TLIF or PLIF cage(s) and pedicle screw system independent of this research protocol;

Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;

Facet joint degeneration/osteophyte formation;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) stabilized with pedicle screws

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 6-weeks, 3-months, 6-months, and annually for 5 years

5 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transforaminal Lumbar Interbody Fusion
• Lumbar Interbody Fusion

How Is the Trial Designed?

Group I: Examination Group Experimental Treatment 1 Intervention

There will only be one arm of subjects in this study. The arm will include subjects who plan to undergo a single-level TLIF/PLIF stabilized with pedicle screws and meet all of the eligibility criteria.

Who Is Running the Clinical Trial?

3Spine

Lead Sponsor

Trials

2

Recruited

330+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9650073/

Comparison of long-term outcomes of spinal fusion surgeries ... Spinal fusion supplemented with DIAM substantially reduced the incidence of radiographic and clinical adjacent segment disease.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X24003428

Comparison of patient outcomes of anterior and posterior ... This study confirms that posterior interbody fusions are more common than anterior procedures, though the latter is increasing.

3. aoao.org aoao.org/2022/02/25/lumbar-fusion-success-and-sequelae-a-narrative-review/

Lumbar Fusion Success and Sequelae: A Narrative Review Lumbar fusion has shown improved results over decompression alone or nonoperative treatment, but at an increased cost.

4. nature.com nature.com/articles/s41598-024-81261-w

Comparative analysis of the efficacy of oblique lateral ... While both OLIF and TLIF are effective for treating LDH, OLIF offers superior long-term pain relief, better spinal alignment correction, reduced collapse rates ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03972-6

Surgical outcomes of anterior lumbar interbody fusion in ... According to the modified Macnab criteria, 73% of the patients in this study had successful outcomes (excellent or good). The pain and lumbar ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38455778/

The Safety and Efficacy of Posterior Lumbar Interbody ... The average Oswestry Disability Index (ODI) score improved by 20.4 points from preoperative measurements (p = 0.0002), and the visual analog ...

7. ijssurgery.com ijssurgery.com/content/early/2024/11/18/8661

Safety of Outpatient Anterior Lumbar Interbody Fusion ... These meta-analyses suggest that outpatient ALIF is associated with a statistically significant decrease in postoperative adverse events.

8. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-08094-6

Efficacy and safety of lateral lumbar interbody fusion for ... This study includes research comparing LLIF combined with auxiliary posterior fixation versus stand-alone LLIF in the treatment of lumbar degenerative disease.

9. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/39/3/article-p380.xml

Complications associated with single-position prone lateral ... Lateral lumbar interbody fusion (LLIF) is a workhorse surgical approach for lumbar arthrodesis. There is growing interest in techniques for ...