LimiFlex vs Fusion Surgery for Spinal Stenosis

Recruiting at 29 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Empirical Spine, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Discogenic pain, Peripheral neuropathy, Previous surgery, Severe osteoporosis, others

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

Compensation: Varies

Number of Visits: 7

Duration: Procedure

299 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive or long-term steroid therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment LimiFlex vs Fusion Surgery for Spinal Stenosis?

Research shows that interspinous implants, like LimiFlex, can be an effective alternative to traditional fusion surgery for spinal stenosis, offering significant pain relief and improved function without increasing stress on nearby spinal segments. Fusion surgery, such as posterior lumbar interbody fusion (PLIF), is also effective, with a high rate of good outcomes, but may lead to increased motion in adjacent segments. ^{1 2 3 4 5}

Is LimiFlex generally safe for humans?

The research articles focus on different types of spinal fusion surgeries, which are not directly related to LimiFlex. They discuss complication rates and adverse events for various fusion techniques, but do not provide specific safety data for LimiFlex. ^{6 7 8 9 10}

How does the LimiFlex treatment differ from other treatments for spinal stenosis?

LimiFlex is a dynamic stabilization device that aims to maintain flexibility in the spine, unlike traditional fusion surgery which can significantly reduce flexibility. It is used in combination with dorsal decompression to prevent instability without the complications associated with fusion, such as stress on adjacent spinal segments. ^{1 5 11 12 13}

What is the purpose of this trial?

The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.

Research Team

Rick Sasso, MD

Principal Investigator

Indiana Spine Group

William C Welch, MD

Principal Investigator

Pennsylvania Hospital Neurosurgery

Eligibility Criteria

Adults aged 25-80 with Grade I degenerative spondylolisthesis and lumbar spinal stenosis, experiencing leg pain or weakness after at least 3 months of non-surgical treatment. Candidates should have a certain level of disability and pain as measured by ODI and VAS scales, suitable anatomy for the device post-decompression, and be able to consent to study requirements.

Inclusion Criteria

Patients must have a pre-operative Visual Analog Scale (VAS) leg pain score of ≥50 on a 100 mm scale

I am between 25 and 80 years old and my bones have stopped growing.

I am mentally capable and willing to participate in the study.

Exclusion Criteria

I have severe osteoporosis.

Patients seeking worker's compensation for back pain or spinal condition

Patients currently in another study of an investigational product for a similar purpose

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical decompression and stabilization with either the LimiFlex Paraspinous Tension Band or transforaminal lumbar interbody fusion with concomitant posterolateral fusion

Procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

60 months

Regular visits at 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months

Treatment Details

Interventions

• Fusion Instrumentation
• LimiFlex

Trial Overview The trial is testing the LimiFlex Paraspinous Tension Band's safety and effectiveness against traditional fusion surgery (TLIF/PLF) following decompression in patients with lumbar spinal stenosis caused by spondylolisthesis. Participants are enrolled into either the LimiFlex or TLIF/PLF group at different sites.

Participant Groups

Group I: LimiFlex Experimental Treatment 2 Interventions

Posterior dynamic stabilization with the LimiFlex Paraspinous Tension Band

Group II: Fusion Active Control 3 Interventions

Transforaminal lumbar interbody fusion with concomitant posterolateral fusion with pedicle screw instrumentation

Who Is Running the Clinical Trial?

Empirical Spine, Inc.

Lead Sponsor

Trials

1

Recruited

300+

Biomedical Statistical Consulting

Collaborator

Trials

1

Recruited

300+

Medical Metrics Diagnostics, Inc

Industry Sponsor

Trials

14

Recruited

1,800+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

Findings from Research

In a study of 247 patients aged 50 to 80 with lumbar spinal stenosis, combining fusion surgery with decompression surgery did not lead to better clinical outcomes compared to decompression surgery alone, as measured by the Oswestry Disability Index and a 6-minute walk test at 2 and 5 years post-surgery.

Patients who underwent fusion surgery experienced longer hospital stays, increased operating time, more bleeding, and higher surgical costs, indicating that the additional procedure may not provide sufficient benefits to justify these risks and expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. Försth, P., Ólafsson, G., Carlsson, T., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. [2022]

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

Spinal stenosis and posterior lumbar interbody fusion. [2016]

3. Singapore pubmed.ncbi.nlm.nih.gov

Which is the most effective treatment for lumbar spinal stenosis: Decompression, fusion, or interspinous process device? A Bayesian network meta-analysis. [2022]

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

Effect of the Total Facet Arthroplasty System after complete laminectomy-facetectomy on the biomechanics of implanted and adjacent segments. [2013]

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

Posterior lumbar interbody fusion in the treatment of symptomatic spinal stenosis. [2022]

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

Different Fusion Approaches for Single-level Lumbar Spondylolysis Have Similar Perioperative Outcomes. [2022]

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

Comparison of complication rates of minimally invasive transforaminal lumbar interbody fusion and lateral lumbar interbody fusion: a systematic review of the literature. [2022]

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

Perioperative adverse events after different fusion approaches for single-level lumbar spondylosis. [2022]

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

Adverse Events After Posterior Lumbar Fusion Are Not Sufficiently Characterized With 30-day Follow-up: A Database Study. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse Events Following Posterior Lumbar Fusion: A Comparison of Spine Surgeons Perceptions and Reported Data for Rates and Risk Factors. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Clinical analysis of interspinous dynamic internal fixation with the Coflex system in treating lumbar degenerative disease]. [2011]

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

A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[A Comparison of Dorsal Decompression and Dorsal Decompression Combined with the Dynamic Stabilisation Device LimiFlex™]. [2015]