Clinical trial NCT04318795: MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Stenosis
Keywords: lumbar spinal stenosis
minimally invasive spine surgery
decompression
fusion
randomized controlled trial
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Intermittent claudication with pain or numbness or weakness of lower limb(s) with or without low back pain
* An imaging study (MRI or CT) showing single level lumbar spinal stenosis

Exclusion Criteria:

* Insufficient conservative treatment (6 weeks)
* Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
* Previous spinal surgery
* Other comorbid conditions that contraindicating surgery
* Possible pregnancy that contraindicating radiological examination
* Age less than 18 years old
* Combination with 2°spondylolisthesis or segmental instability (slip distance \>4mm or angle change \>10° in dynamic plain film)
* Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
* Equal to or more than two responsible level

Primary outcomes:
measure: change in Oswestry Disability Index (ODI) score from baseline
timeFrame: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
Secondary outcomes:
measure: change in European Quality of Life-5 Dimensions (EQ-5D) from baseline
timeFrame: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
measure: change in visual analog scales (VAS) from baseline
timeFrame: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
measure: MacNab criteria
timeFrame: 2 month, 6 months, 1 year，2 years and 5 years postoperatively
Other outcomes:
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