LimiFlex vs Fusion Surgery for Spinal Stenosis

Not currently recruiting at 30 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgeries for lumbar spinal stenosis, a condition that narrows spaces in the spine and causes leg pain or numbness. One group will receive LimiFlex, a device that stabilizes the spine without fusion, while the other group will undergo traditional fusion surgery (Fusion Instrumentation). The trial aims to determine which approach is safer and more effective. Individuals with lumbar degenerative spondylolisthesis (a type of spine slippage) and spinal stenosis, who have not found relief from treatments like physical therapy or medications, might be suitable candidates for this trial. As an unphased trial, it provides an opportunity to explore innovative surgical options for those seeking alternatives to traditional treatments.

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 prior data suggests that the LimiFlex Paraspinous Tension Band is safe for treating lumbar degenerative spondylolisthesis with spinal stenosis?

Research has shown that LimiFlex, a new treatment for spinal problems, is safe. Early results from a study indicated that patients tolerate this treatment well. Those who received LimiFlex experienced fewer complications compared to traditional fusion surgery. They also spent less time in the hospital and recovered more quickly.

Regarding side effects, data suggests they are manageable and occur less frequently than with fusion surgery. Patients generally recovered smoothly without major issues. Although more research is ongoing, current findings are encouraging about the safety of LimiFlex for treating spinal stenosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

LimiFlex is unique because it introduces a new approach to treating spinal stenosis by using a posterior dynamic stabilization system known as the Paraspinous Tension Band. Unlike traditional fusion surgeries, which involve permanently joining vertebrae with screws and rods, LimiFlex aims to preserve more natural movement of the spine. Researchers are excited about LimiFlex because it potentially reduces recovery time and maintains spinal flexibility, offering patients a less invasive alternative to standard spinal fusion procedures.

What evidence suggests that the LimiFlex Paraspinous Tension Band is effective for spinal stenosis?

This trial will compare the LimiFlex™ Paraspinous Tension Band with traditional fusion surgery for treating lumbar degenerative spondylolisthesis with spinal stenosis. Research has shown that the LimiFlex™ device could effectively stabilize the spine after surgery to relieve nerve pressure, offering an alternative to traditional fusion surgery. The tension band permits more natural spine movement compared to the stiffness of fusion. Patients who used it reported less pain and improved mobility. Although more research is underway, early results suggest promising effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Rick Sasso, MD

Principal Investigator

Indiana Spine Group

William C Welch, MD

Principal Investigator

Pennsylvania Hospital Neurosurgery

Are You a Good Fit for This Trial?

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

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

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

Prisoners

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03115983

Study Details | NCT03115983 | LimiFlex ... The LimiFlex™ Paraspinous Tension Band is a new stabilization option for patients being treated with surgical decompression for degenerative spondylolisthesis.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943015000042

a novel treatment method for patients with lumbar spinal ... Decompression and paraspinous tension band: a novel treatment method for patients with lumbar spinal stenosis and degenerative spondylolisthesis.

3. stanfordhealthcare.org stanfordhealthcare.org/trials/l/NCT03115983.html

LimiFlex Clinical Trial for the Treatment of Degenerative ... The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/spondylolisthesis

UCSF Spondylolisthesis Clinical Trials for 2025 The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of ...

5. clinicaltrial.be clinicaltrial.be/en/details/9028?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

LimiFlex Clinical Trial for the Treatment of Degenerative... The LimiFlex™ Paraspinous Tension Band is a new stabilization option for patients being treated with surgical decompression for degenerative ...

6. limiflex.com limiflex.com/news/hcvi6gcn5suwzwlo6qq4lnt25bgwwu

IDE Study Data Demonstrate Shorter Length of Stay and ... IDE Study Data Demonstrate Shorter Length of Stay and Recovery Time for Patients Treated with Limiflex™ Dynamic Sagittal Tether™ (DST) ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943020304046

80. FDA trial of decompression and paraspinous tension ... The purpose of this study is to assess the operative safety and short-term outcomes of decompression and PTB compared to transforaminal lumbar interbody fusion ...

8. openorthopaedicsjournal.com openorthopaedicsjournal.com/VOLUME/17/ELOCATOR/e187432502303170/FULLTEXT/

Interim Results from an FDA IDE Trial. Preoperative through 3-month outcomes and safety data from the IDE study (NCT03115983) are presented here. All patients had symptomatic Grade I ...

9. orthosurgery.ucsf.edu orthosurgery.ucsf.edu/research/clinical-research/Spine-Clinical-Outcomes-Research-Center

Spine Clinical Outcomes Research Center This study aims to demonstrate the safety and effectiveness of the Empirical Spine LimiFlex™ Paraspinous Tension Band when used for spinal stabilization, at one ...