NCT04318795

MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	minimally invasive spinal decompression (MIS-D)	lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation
PROCEDURE	minimally invasive spinal decompression and fusion (MIS-TLIF)	lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-12-31
• Completion: 2025-12-31
• First posted: 2020-03-24
• Last updated: 2020-03-26