MILD Procedure for Lumbar Spinal Stenosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two procedures to determine which is more effective for individuals with lumbar spinal stenosis (LSS), a condition causing pain and discomfort in the lower back and legs. The study examines the frequency of additional surgeries or procedures needed after initial treatment. It compares the MILD procedure, a minimally invasive treatment, with interspinous process decompression. Individuals with Medicare who have been diagnosed with LSS and have not undergone major back surgery in the past year may be suitable candidates for this trial.
As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the development of effective treatments.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the MILD (Minimally Invasive Lumbar Decompression) procedure is generally well-tolerated by patients. Studies have found it safe and effective for treating lumbar spinal stenosis, a narrowing of the spinal canal. Over a two-year period, the spine showed no signs of instability, and the need for additional surgeries or spinal fractures remained low.
The safety of the MILD procedure is comparable to other treatments like interspinous process decompression, another minimally invasive option. Both procedures yield similar safety results, though the MILD procedure has slightly higher rates of follow-up surgeries. Overall, evidence supports the MILD procedure as a safe choice for patients considering this treatment.12345Why are researchers excited about this trial?
Researchers are excited about MILD® Percutaneous Image-Guided Lumbar Decompression because it offers a minimally invasive option for treating lumbar spinal stenosis (LSS) with neurogenic claudication. Unlike more invasive surgeries, MILD uses a small incision to remove excess ligament tissue that narrows the spinal canal, potentially reducing recovery time and complications. Additionally, this procedure is guided by imaging, which enhances precision and safety. This approach provides an alternative to traditional spinal surgeries, which often require longer recovery periods and carry higher risks.
What evidence suggests that this trial's treatments could be effective for LSS with NC?
Research has shown that the MILD procedure, one of the treatments studied in this trial, can help treat lumbar spinal stenosis, a narrowing of the spinal canal in the lower back that causes pain and stiffness. One study found that patients experienced significant symptom improvement and maintained these benefits over time. Another study reported that 88% of patients did not require additional surgery for at least five years after undergoing the MILD procedure. Additionally, there was no indication of spinal instability or an increased need for further surgery during a two-year follow-up. These findings suggest that MILD can provide lasting relief for individuals with chronic back pain. Another treatment option in this trial is interspinous process decompression, which is also being evaluated for its effectiveness in treating lumbar spinal stenosis.12678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the MILD procedure or IPD for the treatment of LSS
Follow-up
Participants are monitored for reoperation and harms data using Medicare claims data
What Are the Treatments Tested in This Trial?
Interventions
- MILD
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)).
All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stryker Instruments
Lead Sponsor
Vertos Medical, Inc.
Lead Sponsor
Citations
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.
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.
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 ...
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 ...
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/vertos-medical-announces-mild-procedure-long-term-safety-and-efficacy-data/Vertos Medical Announces mild® Procedure Long-term ...
The data affirms long-term safety and efficacy of the mild® lumbar decompression procedure, a clinically proven outpatient procedure that ...
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.
The Role of Minimally Invasive Lumbar Decompression ...
The MILD procedure involves the removal of excess hypertrophic ligamentum flavum that contribute to the narrowing of the spinal canal. Ideal ...
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