Retrospective Review of the Outcomes of 300 Minimally Invasive Lumbar Decompression® Cases: Real-World Outcomes
Christopher Zhang1, Courtney Aronica1, Sudhir A Diwan2
1Northwell Health Department of Physical Medicine and Rehabilitation, Manhasset, NY.
Background:
Lumbar spinal stenosis (LSS) is a prevalent cause of pain and disability in elderly individuals, characterized primarily by neurogenic claudication resulting from narrowed spinal canals. Traditional treatment for LSS spans from conservative approaches to decompressive surgery, the latter of which poses significant complication risks. Minimally Invasive Lumbar Decompression® (MILD®, Vertos Medical) offers a less invasive alternative, with its efficacy supported by preliminary studies such as the MiDAS ENCORE.
Objective:
This retrospective study evaluates the real-world outcomes of the MILD® procedure in managing LSS accompanied by hypertrophied ligamentum flavum (HLF) in 300 patients who have failed conservative management.
Study Design:
A single-center observational study.
Methods:
We conducted a retrospective review of 300 patients treated with MILD® at a single center in Northern New Jersey. Patients had documented cases of central LSS with HLF and persistent symptoms despite being treated with conventional therapies. The procedure involved percutaneous lumbar decompression using fluoroscopic guidance. Outcomes measured included scores on the Numeric Pain Rating Scale (NPRS) and patient-reported improvement percentages at intervals of up to one year.
Results:
MILD® significantly reduced NPRS scores at all follow-up points, with the most substantial improvements noted within 3 months after the operation and sustained benefits up to a year. The average patient-reported improvement in pain and function was robust, beginning as early as 2 weeks after the procedure. No serious adverse events were reported, affirming the procedure's safety.
Limitations:
The absence of a control group and the study's single-center nature might have limited the generalizability of results. These factors highlight the necessity for multicenter controlled trials to validate findings across diverse populations.
Conclusion:
The MILD® procedure is a safe and effective treatment for LSS, providing significant and sustained improvements in pain and function, making the technique particularly suitable for patients ineligible for surgery or at higher risk of experiencing complications from it.
