MILD Procedure for Lumbar Spinal Stenosis

Not currently recruiting at 25 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vertos Medical, Inc.

Must be taking: Opioids

Must not be taking: Epidural injections

Disqualifiers: Low ODI/NPRS scores, Prior surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help people with lumbar spinal stenosis (LSS), a condition where the spinal canal narrows, causing back and leg pain known as neurogenic claudication. Researchers aim to determine if a minimally invasive procedure called MILD (Minimally Invasive Lumbar Decompression), combined with usual medical care, improves symptoms more effectively than standard care alone. People who have experienced LSS symptoms for at least three months and have managed them with stable medication might be suitable candidates. The study seeks to provide real-world data on whether the MILD procedure can serve as a first-line treatment for LSS. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could redefine treatment options for LSS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, your opioid intake must be stable with no changes for 30 days before joining the study.

What prior data suggests that the MILD procedure is safe for lumbar spinal stenosis patients?

Research has shown that the MILD procedure is generally safe for treating lumbar spinal stenosis. Studies indicate it has a good safety record, rarely causing serious issues. One study found that patients did not experience spinal instability, a serious risk, over two years. Another study supported these results, showing no major safety concerns over three years. The MILD procedure is considered as safe as other similar treatments. Overall, it appears to be a well-tolerated option for people with lumbar spinal stenosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MILD (Minimally Invasive Lumbar Decompression) procedure for lumbar spinal stenosis because it offers a new, less invasive approach to treatment. Unlike traditional surgical options that often require large incisions and longer recovery times, the MILD procedure uses an image-guided technique to precisely target and remove small pieces of bone and thickened ligament through a tiny incision. This minimally invasive method aims to decompress the spinal canal, potentially reducing pain and increasing mobility with less downtime and fewer risks compared to conventional surgery. Additionally, when combined with conventional medical management (CMM), it might enhance overall patient outcomes by integrating both innovative and standard care practices seamlessly.

What evidence suggests that the MILD procedure is effective for lumbar spinal stenosis?

This trial will compare the MILD procedure, which stands for Minimally Invasive Lumbar Decompression, with Conventional Medical Management (CMM) for patients with lumbar spinal stenosis. Studies have shown that the MILD procedure can effectively help manage chronic pain. Research indicates that patients who underwent the MILD procedure experienced significant symptom improvements over time. Specifically, one study found that 88% of patients avoided more invasive surgeries for at least five years while still experiencing relief. Additionally, long-term research demonstrated that the procedure remained beneficial and did not cause spinal instability. Overall, the MILD procedure appears to be a promising option for those seeking to improve their condition without major surgery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for people with lumbar spinal stenosis causing leg pain when walking. Participants should have certain spine conditions like bone spurs or minor slipped discs but not severe ones, stable opioid use, and no recent back procedures. They must be able to attend follow-ups and haven't had the MILD procedure before.

Inclusion Criteria

I have spinal issues like osteophytes or disk protrusion but my doctor says they're not too advanced.

I can attend all required follow-up appointments.

I have had leg pain from nerve issues for at least 3 months.

Exclusion Criteria

I have had spinal fractures and still experience pain from them.

On (or pending) Workman's Compensation or known to be considering litigation associated with back pain

My doctor says fat buildup in my spine is causing narrowing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MILD procedure with conventional medical management or conventional medical management alone

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Annual visits

Long-term follow-up

Participants are followed for up to 5 years to assess long-term outcomes

5 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Medical Management (CMM)
• MILD Procedure

Trial Overview The study compares two treatments: the MILD procedure plus usual care versus just usual care for spinal stenosis. It's a randomized controlled trial where some patients can switch to MILD after one year if they were initially in the control group.

How Is the Trial Designed?

Group I: MILD with CMM Active Control 2 Interventions

The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment

Group II: CMM alone Active Control 1 Intervention

Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Who Is Running the Clinical Trial?

Vertos Medical, Inc.

Lead Sponsor

Trials

10

Recruited

8,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12262078/

Minimally Invasive Lumbar Decompression (MILD) in Patients ... This systematic review suggests that the MILD procedure can be effective in managing chronic pain patients with lumbar spinal stenosis.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000226

Three-year results of the MOTION randomized controlled ... Significant and substantial improvements in all the outcomes were observed from baseline to follow-up for patients treated with the mild Procedure. These ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6319572/

Long-Term Safety and Efficacy of Minimally Invasive Lumbar ... MILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are ...

4. asra.com asra.com/docs/default-source/events-education-documents/pm24/abstract-6323.pdf

Outcomes of The Minimally Invasive Lumbar ... Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis. Patients Treated with the mild Procedure: One-Year Results.

5. vertosmed.com vertosmed.com/cleveland-clinic-5-year-study-demonstrates-mild-saved-88-of-patients-from-open-surgery-while-providing-significant-symptom-relief-2/

Cleveland Clinic Spinal Stenosis Study Shows mild® 5- ... 5-year study demonstrates 88% of mild patients avoided surgical decompression for at least 5 years while experiencing significant symptom relief.

6. vertosmed.com vertosmed.com/the-motion-study-a-randomized-controlled-trial-with-objective-real-world-outcomes-for-lumbar-spinal-stenosis-patients-treated-with-the-mild-procedure-1-year-results/

1-Year Treatment Results w/ mild®Procedure The purpose of this study was to provide Level-1 objective, real-world outcome data for patients with lumbar spinal stenosis (LSS).

7. rapm.bmj.com rapm.bmj.com/content/49/1/30

Comparison analysis of safety outcomes and the rate of ... These results showed ISD and MILD procedures have an equivalent safety profile. However, ISDs demonstrated lower rates of open decompression and MILD.