Spinal Stenosis Clinical Trial
Official title:
Minimally Invasive Spinal Decompression (MIS-D) Versus Minimally Invasive Spinal Decompression and Fusion (MIS-TLIF) for the Treatment of Lumbar Spinal Stenosis (LSS): A Prospective Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in terms of clinical outcomes, complications, reoperations, and other perioperative data.
Lumbar spinal stenosis (LSS) is one of the most common degenerative spine diseases in older
people and is associated with mechanical low back pain, radiculopathy and/or neurological
claudication. The results of The Spine Patient Outcomes Research Trial (SPORT) reported that,
surgical treatment in these patients led to significantly greater improvement in pain and
function than nonsurgical treatment. Nowadays, decompression with instrumented or
non-instrumented fusion is commonly practiced which is regarded as the "gold standard"
surgery for LSS.
Over the last two decades, several retrospective studies comparing the surgical outcomes of
decompression alone and decompression plus fusion for LSS have been published. Most of the
studies concluded that decompression plus fusion had better clinical outcomes compared with
decompression alone. However, in 2016, two randomized control trials (RCT) about LSS were
published in the New England Journal of Medicine (NEJM) and raised some serious questions.
The results of both studies showed that fusion did not have much additional value for
patients with stable LSS, and moreover, it might be regard as an overcautious and unnecessary
treatment, which were contradictory to most of the previous studies.
Over the past few years, minimally invasive spine surgery (MISS) has been improving rapidly
due to the development of related instruments, more experienced surgeons, and patients'
demands. Compared with open spine surgery, MISS has already proved to be associated with less
surgical trauma and rapid recovery with similar clinical outcomes. Minimally invasive spinal
decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) have
been performed widely for the treatment of LSS. However, there is no previous study comparing
MIS-D to MIS-TLIF in terms of clinical outcomes, complications, reoperations, and other
perioperative data. Therefore, a randomized controlled trial comparing these 2 common MISS
techniques is warranted.
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