Minimally Invasive Lumbar Decompression: A Review of Indications, Techniques, Efficacy and Safety

Abstract

<jats:p> Lumbar spinal stenosis is a common degenerative spine condition. In properly selected patients, minimally invasive lumbar decompression ( mild<jats:sup>®</jats:sup>) may be an option to improve outcomes. This review provides an in-depth description of the mild procedure and a comprehensive examination of safety and efficacy. Two randomized controlled trials, together with 11 other controlled clinical studies, have established the efficacy of mild, which is a minimally invasive procedure that does not involve implants and has demonstrated excellent efficacy and safety. With an established safety profile equivalent to epidural steroid injections, and efficacy that has been shown to be superior to such injections, mild can reasonably be positioned early in the treatment algorithm for these patients. Based on extensive review of the literature, robust safety and efficacy through 2 years, and in accordance with minimally invasive spine treatment guidelines, mild is recommended as the first intervention after failure of conservative measures for lumbar spinal stenosis patients with neurogenic claudication and ligamentum flavum hypertrophy. </jats:p>

Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial

“…These refractory patients represent a significantly different patient profile than those early in the continuum of care. 4 , 7 While the clinical superiority of mild to ESIs/CMM has been established by this and two other RCTs, 19 , 20 a suggested comparison of mild to open surgery presents several methodological challenges. First, these patient populations are at completely different phases on the treatment algorithm.…”

“…This level of safety for the mild Procedure is supported by 13 clinical studies, including 2 Level 1 RCTs, that have demonstrated statistically significant efficacy improvement, superiority of mild versus ESIs, and low complication rates. 4 , 7 , 18–20 In fact, the safety of mild has been shown to be similar to ESIs at a 1.3% rate of device or procedure-related complications for both study groups in the ENCORE RCT. 19 It is important to note that all conservative and interventional therapies included in CMM in the MOTION study are positioned early in the treatment algorithm due to their low risk ( Table 4 ).…”

“…mild leaves no implants behind, and patients typically resume normal activity within 24 hours with no restrictions. 4 , 7 , 11 The mild Procedure has been previously described. 7 All study mild Procedures were conducted in accordance with the product labeling and indications for use.…”

A Retrospective, Single-Center, Quantitative Analysis of Adverse Events in Patients Undergoing Spinal Stenosis with Neurogenic Claudication Using a Novel Percutaneous Direct Lumbar Decompression Strategy

“…Published data suggest that this percutaneous direct decompression therapy has a high rate of success with limited risk. 3 For the Mild procedure, a five-point mean numeric pain-rating scale improvement 4 with mean ODI responder improvement of 32 points, 5 indicating significant pain reduction and functional improvement, has been achieved at 2-year follow-up. Historically, percutaneous direct decompression was performed by initially placing an epidural at the level or the level above the spinal stenosis.…”

“… 3 Although these data exist, patient selection for treatment candidacy and the procedure itself are evolving. 4 Percutaneous direct decompression procedurally has evolved from a dedicated ipsilateral incision and epidurogram to a midline incision with or without the need for an epidurogram. Although this has been employed in clinical practice, there has been no formal investigation of the safety of percutaneous direct decompression without the use of an epidurogram and relying on osteal landmarks.…”